Tips on preparing for Trump Presidency


For Dems, #DNC2016 is the time, right down to the wire, to get on board with our hearts & minds to save our soul and support whole heartedly #ClintonKaine. But if we don’t do that, then here are some tips, how I am getting ready for Trump Presidency.

To my Muslim friends: I want to take the opportunity to bid you teary farewell.  It’s been a pleasure knowing you – some of you lived here, before I stepped foot in America, some of you were born here and some chose this as a path to your own spiritual journey. You will all be sorely missed. As American refugees, you will have to find a friendly country, to take you in. All of you please don’t go to Canada, lest we are forced to build another wall at the other border or worse still, force our friendly neighbor to pay for the wall.  I’ve heard, there is an island somewhere in the Pacific, but as an American, I don’t have much more information – despite Galileo’s insistence so long ago, we in America, tend to believe that we are the center of the universe and have very little information about the rest of the world.  Feel free to check google, for information and directions to a friendly nation to take you in.

Yes, America might be built on people escaping persecution, on the basis of race and religion, but under Mr. Trump, we are doing a flip on everything we had believed in:   https://www.youtube.com/watch?v=XMbBYd7gz40

I would like to remind my Muslim friends to take enough food to last for 8 years (hope it is enough time to memorize the phrase “I don’t believe in Sharia”; meanwhile we will work to get you in at the end of eight years. But just in case we are not successful, please learn to grow your own food.  Don’t think however for a minute that like Japan, you will get away with exporting your surplus food to the US, unless you are willing to take… err let’s see what America exports… one of our top exports is art and antiquities (some of which can include our highly prized guns that are now antique items as we all use semis…  Yes, so be prepared to import our stuff. Oh and don’t ever go celebrating the attacks on Americans, like you did, after 9/11.

To my “Mexican” friends: It doesn’t matter how long ago you came to this country, you might as well start packing your bags too. Think about how fortunate you are —- unlike my Muslim friends, at least you don’t have to waste time trying to find directions to a friendly nation — you can take the same tunnel back (the one you used 55 years back) — or President Trump might even open the BIG DOOR to let you out.  Also he has promised that you will be “rounded up in a very nice and humane way”.  About your children born here?……. Errr well….for the time being, feel free to leave them here…(but don’t quote me, I’ve to check the policy on this one).
https://www.youtube.com/watch?v=QUPdVTMwOGo

To my Mentally Unstable friends: I am sorry, we are not likely to have mental health services in the budget.  But fear not, we are making America safe again, and we plan to build more prisons.  Should you happen to put your hands onto one of those easily available weapons of mass destruction, we will house you in our state of the art penitentiary with solitary confinement cells.  But please be in the state with no death penalty laws, else you are out of luck and you can pray that the drug cocktail you receive will be sound enough to do a quick job.

To my African American friends: What!!!  Where did you come up with “black lives matter” concept? What an original and absolutely foolish idea?  We may not believe that “all men are created equal” or in the unalienable rights of life, liberty, and the pursuit of happiness, but come on, everyone knows that all lives matter. I’m sure Trump’s African American knew that. So please get a handle on yourselves.  Oh and haven’t you seen Mr. Trump’s retweets of crime statistics with much higher rates of black people killing whites. Ok, so these inflated statistics and most of all other stats quoted by Mr. Trump are wrong, but we all know statistics lie. So just believe it, because Mr. Trump says so, just like the 70% of us voting for Trump know in our hearts “he will shake things up” and as long as he says so; we don’t ask him or care to know “how” he will do it.
http://www.slate.com/articles/news_and_politics/cover_story/2016/07/donald_trump_is_unfit_to_be_president_here_are_141_reasons_why.html
BTW watch at 1:45 on how white people don’t get locked up – https://www.youtube.com/watch?v=lpgupYoTZXc

To my Japanese American friends:  First of all, let us defend history, history is always right and Japanese internment might have been the right thing to do.  If you have pledged allegiance to the United States then you should agree that it is important to win at all costs.  Come on, join Mr. Trump and “win a few wars”, then you’ll get the idea.

To my LGBT and Q friends: Please don’t consider yourselves special interest group. “One thing that distinguishes President Trump from the other Republican leaders are his liberal views on LGBTQ issues”.  He even congratulated two men on their marriage, in 2005.  Some time back, Mr. Angelo, President of a Republican group that supports gay rights, said about Mr. Trump that he will be the most gay friendly President ever.  Yes, Mr. Trump did bring in an evangelical, Mr Pence as his running mate (https://www.youtube.com/watch?v=99WSEFUy-2o) , but Mr, Trump is not in the habit of listening to anyone, or backing down from pressure; so fear not.  He does do flip-flops depending on his mood but he also does flip-flops on his prior flip-flops; so be optimistic.
Trump vs. Trump on Stephen Colbert: (watch around 3:20)  https://www.youtube.com/watch?v=WpKiP_gmDS8

To my Police officer friends: You will get all the help you need from President Trump, except for gun reform. Please forget about your demands for restrictive gun laws.  Mr, Trump has said that the “police are the most mistreated people in America and we have to give the power back to the police, because crime is rampant in America”.  Now you might say, you’ve been doing a great job and crime rates have actually been falling for decades.  But numbers lie, and we all need to have blind faith in President Trump; with rhetoric, he will make America safe again.  So relax, don’t worry about snipers perched atop tall buildings targeting the cops, they are expected to run when they hear Mr. T’s rhetoric.

To Parents: New rules… aww just as we learn to raise kids, the rules change upon us.  But it is now proven that teaching kids violence, rudeness, lies, and equipping them with inflated ego, will get them places. Oh also plagiarism is in and they must never take responsibility, if caught doing any of these. If you want your children to succeed in life, then it falls upon you to impart proper values as exhibited by Mr. T, (as help, look out for soon to be out “A child’s first book on Trump” that can help explain to a child what a trump is).  Your children will never again have to think before saying something (it is called political correctness and it is out). See how our President has perfected the art of lying, we may offer degrees in lying at one of the Trump universities: (he lies every 5 minutes (must-see): https://www.youtube.com/watch?v=dmne8r2sIFA
CNN busts Trump on lying https://www.youtube.com/watch?v=Vz1F58BvlE0
Trump’s top 10 lies from his pausing as his publicist, to inflated crime numbers to deflated employment numbers to his bankruptcy to his stance on women to his donating money: https://www.youtube.com/watch?v=xrf9H97PiQk   

To job seekers: As a recruiter, I have to add this little piece of advice. While Mr. Trump is going to make America work again, remember, when you apply for jobs, you shall be judged on the basis of your heritage and your race will be invoked when assessing your qualification to do your job.  Consider your vocation carefully – if you are a Mexican American then forget about aspiring to be a judge….
https://www.youtube.com/watch?v=_4U7yRHZIz4

To Mr. John McCain (decorated Vietnam war veteran – before Mr Trump brought us to reality): How can you be captured? Don’t you know that winners never get captured? Mr. Trump has lied and lied and lied and has totally evaded capture — now that defines a winner, doesn’t it?  I could have picked any number of hundreds of thousands of leaders but I picked you Mr. McCain, as an example to send the message out to the entire military – please evade capture, under all circumstances because if you do get captured by the enemy then you will have more to fear from your own countrymen than the enemy.

To my technology sector friends and leaders (except our prominent gay person, Mr. Theil):
We have read your letter and seen your fears that Trump Presidency could mar innovation.  But fear not…. Or remember, there is lot more to fear than that… For instance, watch Seth Meyers at 2 min. (on death, destruction, and weakness):
https://www.youtube.com/watch?v=RGKcIIm_VeU  And remember, innovation is not all what it’s made out to be… After all, Melania Trump’s speech was the best speech at #RNC2016, wasn’t it?

To my lawyer friends: Relax, President Trump will love you, your jobs are secure.  From being sued for defamation etc. to suing people, Mr Trump will keep you busy.
https://www.youtube.com/watch?v=UGPvwdrlzCM (watch at 7 minutes)
John Oliver on Trump’s 3500 law suits https://www.youtube.com/watch?v=abh00vu1mVA  President Trump will also likely pay legal fees for all who incite or engage in violence, on his behalf https://www.youtube.com/watch?v=JiZ_YP–mIg .

To my girlfriends: Come on…. If his views on women bothered you then we wouldn’t be here, would we?  But how much do you want people to trust you, “with blood coming out of whereever”; which may be the reason that every time President to be Mr. Trump insulted one of us, his ratings only went up.
Trump’s views on women: https://www.youtube.com/watch?v=UGPvwdrlzCM  https://www.youtube.com/watch?v=uM19yt7MbN8  But still to appease you, he has engaged his daughter to vocalize some women’s causes, now and then, so you are expected to be on board.

To young people: Same as above — if you cared, we wouldn’t  be here.
But then again… shame on you Hillary, for not connecting with our young people and their many causes:  https://www.youtube.com/watch?v=C7dxBlTC_9c As our young people, you are the only group, we are not yet certain of; if you are on board with Trump Presidency.  But those of us getting ready for Trump Presidency are not too worried as the Hillary camp has also not yet figured out how to get you on board. I’ve heard people say that you want free stuff that dad Bernie promised. But I think, you want to be heard and understood and you want others to appreciate your challenges. Now, that’s asking for too much! My advice? No one’s listening in this election; if you just sit out and don’t vote then we anticipate that should ensure a sure victory for President Trump.  So please stay out, nurse your pain, (opioids are easily available) and see you in 8 years when you are older and more disillusioned – then you’ll just want to be right, rather than do right (as Mr. Tim Kaine said), so our party will get  you then.
Watch at 28 min. https://www.youtube.com/watch?v=HK9AmZftdWw

To my friends in the media: To Washington Post, Jack Tapper, Trevor Noah, John Oliver, Seth Meyers, John Stewart, Bill Maher, Rachel Maddow, Hasan Minhaj (in fact, I did not find one Trump-friendly media source — so you all out there) – you should start fearing for your jobs.  Many of you are banned from President Trump’s media updates and President Trump has promised to sue the media for libel (yes, one of the first things he plans to work on is to repeal the law that bans politicians from suing the media for spreading accurate information – so beware!

Seth Meyers’ closer look – https://www.youtube.com/watch?v=z8rVfTAwi_M
https://www.youtube.com/watch?v=RGKcIIm_VeU  Watch at 2 min (death, destruction and weakness)
141 things he has said that makes him unfit to be a president http://www.slate.com/articles/news_and_politics/cover_story/2016/07/donald_trump_is_unfit_to_be_president_here_are_141_reasons_why.html
MSNBC: https://www.youtube.com/watch?v=zdagdK0O0GM
John Oliver: watch from 2 min. On https://www.youtube.com/watch?v=zNdkrtfZP8I – (understandable that politicians may wish to go with feelings of people but if you plan to vote, are you going to with feeling or fact?)

TO TERRORIST ENEMIES: Just like Hillary Clinton, freshly elected President Trump is not likely to be friendly towards you, at least not initially.   While you will be water-boarded and while we are working on “becoming you”, “becoming evil”, you may want to consider this…, we don’t have a real strategy to deal with you but we have faith that Mr Trump is our law and enforcement guy.  Also, President Trump has never been against all Muslims.  He has given a ringing endorsement to former President of Iraq, Mr. Saddam Hussein, who was in fact a Sunni Muslim.  No promises here, but if you can figure out how Saddam Hussein emerged as Mr. Trump’s role model (even while Mt. T acknowledges that he was a bad guy) then you may figure out how to get Mr. Trump to be your friend. With Hillary Kaine ticket, it is absolutely not going to happen – she has experience and resolve to quosh terrorists.
https://www.youtube.com/watch?v=HxUYfjuLkQg  

To WHITE SUPREMACIST TERRORISTS: Oh… you are one step ahead and well on your way to bonding with Mr. Trump.
https://www.youtube.com/watch?v=N7u3fFhOf3o
https://www.youtube.com/watch?v=n5q1cxIU01M

Finally to all my friends: If I could, I would reach out individually to all of my 10,000+ friends and contacts on various social media channels, because Trump presidency is likely to touch each one of us in various ways.  But really, consider this an advance notice and start preparing…. However, if you feel overwhelmed with how much all our lives will be shaken up and there just isn’t enough time to prepare for it, then there is still time for an alternative.  With #ClintonKaine ticket, there may also be some disorganization but there is less rhetoric and more strategy and experience; there is humility and respect for the top job; there is experience in building alliances to get things done; there is genuine inclusiveness and respect for differences; and there is respect and promise to reach out to those more fortunate and privileged and there is real compassion and caring for those whose lives can be made better.  In short, they have a recipe for moving us forward. Clinton and Kaine will reach out and tap into their colleagues’ experiences for a stronger, forward-looking America.  If you get on board for voting with your conscience and give a strong endorsement to Clinton and Kaine then you can relax.  The pressure is off.  But former President Mr. Bill Clinton better start learning how to throw the right kind of parties and pick out the right china.
Seth Meyers: It’s funny, but it’s serious, how he’s funding his campaign: Seth Meyers: https://www.youtube.com/watch?v=DnpO_RTSNmQ
Trevor Noah (no Clinton has weeknesses but Trump?:   https://www.youtube.com/watch?v=NS3Ow6V1htM
Seth Meyers (ClintonKaine stay off of engaging with Trump on social media & stay focused on and tweet us your strategy) https://www.youtube.com/watch?v=lJWIbxZmwMA
Bill Maher (at 3 min): https://www.youtube.com/watch?v=3YWGc_4ZcTM
Bill Maher: https://www.youtube.com/watch?v=DnK8Z6oAmjE
Bill Maher: https://www.youtube.com/watch?v=OblrmGQzMLQ

 

2 Comments

Green Day’s American Idiot – Play Review


Directed by Jeffrey Bracco, “Green Day’s American Idiot” at CityLights  www.cltc.org in San Jose, tells the powerful story of young people on their own quest for meaning in life. The story is set in a post 9/11 time in history, but it can be true of any time when society is preoccupied with its own challenges, when the young people are forgotten, and left to walk their own path of broken homes and broken dreams.  The musical made its debut on Broadway in 2010 and earned a Tony Award nomination for Best Musical.  Punk rock band, Green Day with vocalist/ guitarist Billie Joe Armstrong has scored several hit albums and top selling songs.

Don’t wanna be an American idiot.
Don’t want a nation under the new mania
And can you hear the sound of hysteria?
The subliminal mind fuck America.
Welcome to a new kind of tension.
All across the alienation.
Where everything isn’t meant to be okay.
Television dreams of tomorrow.
We’re not the ones who’re meant to follow.
For that’s enough to argue.

“Dearly beloved, are you listening?”   These are not just “Tales from another broken home”.  Each one is a story oozing with pain and a gripping sense of alienation.

I’m the son of rage and love
The Jesus of Suburbia
From the bible of none of the above
On a steady diet of
Soda pop and Ritalin
No one ever died for my sins in hell
As far as I can tell
At least the ones I got away with
And there’s nothing wrong with me
This is how I’m supposed to be
In a land of make believe
That don’t believe in me

Buried in an all consuming sense of meaninglessness and alienation among many young people (nearly two dozen actors), is the story of three teenagers, Johnny (Joey Piscane), Tunny (Andrew Erwin), and Will (Tarif Pappu).  In a life devoid of meaning and excitement, their minds saturated with violent TV programs, they decide to leave their homes and escape to the city.  But Will’s girlfriend Heather (Melissa Baxter) gets pregnant.  Meanwhile, in the city, Johnny falls for Whatsername (Danielle Mendoza) but is unable to kick his drug habit.  Tunny goes off to the war in the Middle East and loses a limb in the war, loses his heart to Extraordinary Girl (Taylor Sanders) who nurses his injuries and seemingly loses his mind to narcotics, he’s been taking for pain.  It is heart-rending to see the numbing and overwhelming pain that leaves them little recourse in the present and less hope for the future as these young people are left alone to walk the path of their broken dreams.

Take away the sensation inside
Bitter sweet migraine in my head
It’s like a throbbing tooth ache of the mind
I can’t take this feeling anymore
Drain the pressure from the swelling
The sensation’s overwhelming
Give me a long kiss goodnight and everything will be alright
Tell me that I won’t feel a thing
So give me Novacaine
Out of body and out of mind
Kiss the demons out of my dreams
I get the funny feeling, that’s alright
Jimmy says it’s better than here
I’ll tell you why

Boulevard of broken dreams………

I walk a lonely road
The only one that I have ever known
Don’t know where it goes
But it’s home to me and I walk alone
I walk this empty street
On the Boulevard of Broken Dreams
Where the city sleeps
And I’m the only one and I walk alone
I walk alone
I walk alone
I walk alone
I walk a…
My shadow’s the only one that walks beside me
My shallow heart’s the only thing that’s beating
Sometimes I wish someone out there will find me
‘Til then I walk alone
Ah-ah, ah-ah, ah-ah, aaah-ah,
Ah-ah, ah-ah, ah-ah
I’m walking down the line
That divides me somewhere in my mind
On the border line
Of the edge and where I walk alone
Read between the lines
Of what’s fucked up and everything’s alright
Check my vital signs
To know I’m still alive and I walk alone

There are minimal props in Ron Gasparinetti’s scenic design.  Flickering television screens, few chairs and ladders thrown about and graffiti scattering the floor is a metaphor for the generation left to fend for itself, strewn about and falling through the cracks, surfacing on and off for some air and some hope for the future.   The play will run at CityLights till August, 21st.

1 Comment

JOBS – July, 2016


All US based opportunities require valid US work visa and prior experience in biomedical industry.  Most of my current needs are in engineering and all engineering opportunities require medical device experience.  I have added some other opportunities in science, sales, Business Development etc.

I will be adding more opportunities.  If interested in any opportunities below, please send me an email (resume as an attachment) at wd_darshana at hot mail dot com and include position title in the subject line.  Please include in the email, how well the description matches your background and where the gaps are, if any.  If you identify the position that correctly fits your experience & geographic preference and include in the email details on how it matches your background, your current comp and comp expectations, then it will get my first attention.  All leads or referrals are greatly appreciated.

Patent Paralegal – San Jose, CA

The position will be assisting in-house counsel working on USPTO and foreign filings, office actions, assignments and other related USPTO filings for a variety of medical device and pharmaceutical related patent applications. They will be proofing and editing patent applications and office actions and prepping office actions. They will be developing and tracking dockets (US and foreign), filing on line assignments, working with the deposit accounts and reviewing IP related documents and agreements.

Requirements:

  • Four year college degree. Paralegal certificate preferred but not required
  • 5 years of paralegal experience mainly with the U.S. patent prosecution and some foreign prosecution and trademark work
  • Excellent computer and typing skills (including proficiency on Word and Excel), proof and editing skills
  • Comprehensive knowledge of USPTO patent procedures and patent claim format
  • Experience with docketing tracking software and patent licenses are a plus
  • Technical background and prior experience with medical device and drug related patents is preferred

Director of Engineering – San Jose, CA
(Medical device implantable experience and hands-on engineering passion required).

Automatic Test Equipment Engineer – San Jose, CA
Immediately available.  Requires medical device experience. Send in resume ASAP.

Manufacturing Quality Engineer – San Jose, CA
Immediately available. Please send in resume ASAP.

Biochemist – San Jose, CA
Requires MS with 6+ years experience or PhD with 3 years experience in Biochem, Molecular Biology or related.  Immediately available, send in resume ASAP, if interested.

Quality Assurance Manager – San Jose, CA


Senior Manufacturing Engineer – San Jose, CA


Manufacturing Technician – San Jose, CA


Senior Mechanical Engineer – San Jose, CA

Biologist – San Jose, CA

Software Sales – San Jose, CA
Seed stage company offering a suite of subscription based software products, supported by cloud infrastructure, has an exciting opportunity for software sales professional, to join as member of the core founding team.  Although at pre-funding stage, the company is already generating revenues, with massive and growing database of products that can help scientists make environmentally friendly decisions throughout product development life-cycle.  Extensive customer relationship experience is required.  Familiarity with SciFinder, Reaxys etc. is required.

Engineering Technician – Mt. Laurel, NJ

An innovative medical device company focused on treatment of cardiac diseases, has an exciting opening for Engineering Technician, in Mount Laurel, New Jersey.

Requirements: BS in EE, 3+ years experience as R&D Electrical Engineering Tech/ Testing Engineer, Prior experience in strongly regulated industries (e.g. medical, defense etc.), Prior experience with reliability tests and assembly.

Job functions:
* Conduct all assigned tests, under the direction of a senior engineer.
* Implement reliability test programs and test setups to implement test protocols.
* Conduct and document test protocols in component and system reliability, failure analysis, etc.
* Ensure compliance with regulations including QSR, ISO Standards and corporate policies.
* Specify and purchase components for test setups and prototypes.
* Procure and maintain engineering lab equipment in accordance with quality practices.

Senior Business Development Role – EU

Reporting To: Head – Global BD to manage all aspects of business development across the CRO portfolio of services; secure and retain business through professional, consultative & proactive sales activities directed at key decision makers.

Responsibilities:
Maintain knowledge of all appropriate cross-sell opportunities; Continued awareness of competitive activities, positioning & pricing; Work with regional & international counterparts to develop & close integrated opportunities; Analyze potential opportunities & develop sales plans for each target account; Develop in-depth knowledge of customer organization; Represent company at various industry conferences & trade shows; Prepare & lead sales presentation; Educate team in customer culture, operational needs/methods & sales techniques; Handle follow-up related to sale & drive completion of contract;  Maintain high visibility in customer organization; Monitor customer satisfaction; Record, plan & coordinate customer sales activities in CRM (SALESFORCE) system.

Requirements:  BS or MS in Life Sciences – PhD. preferred; 10+ yrs experience in BD / sales for CRO, CMO or related in life sciences; Ideally industry experience in combination of pharma or biotech in discovery research, CMC or commercial manufacturing technical roles; Solid understanding of drug discovery & development process; Track record of achievement in terms of sales goals; Experience working with international clients & colleagues; Ability to visualize & integrate company’s service portfolio across the drug development continuum;  Ability to cross-sell & credibly represent company services to clients; Ability to work from home-based office

Additional details: The position is located in EU.  Base pay: between 100,000 to 125,000 euros, car: 800 euros per month, VPP: 5% of base pay; Pension benefits: as applicable per country, Designation – Regional Director, BD

Analog Design & Embedded Systems Engineering Leader – San Jose, CA

Innovative, well funded bio-medical startup with disruptive technology has an exciting opportunity for analog design engineering leader, in San Jose, CA. Stock options, in addition to working on something truly exciting and life changing, would be a huge upside in this opportunity.  Requirements include, years of steady experience and passion for engineering problem solving, natural ability to take leadership role (MBA not required). This opportunity is immediately available and if you are engineering problem solver then it is one of the most exciting opportunities you may come across.

Leads Engineer – Austin, TX or San Jose, CA

Requires BS in mechanical engineering, related to biomedical engineering and 10+ years medical device experience.  Highly desired, experience designing and developing medical products with implantable leads like cardiac pacemaker leads, proficiency in CAD, SolidWorks, and experience with MatLab, hands-on experience for fabricating prototype leads and related fixtures and tooling.

Responsibilities:

  • Design and develop new conceptual leads in groundbreaking fields of medical devices.
  • Prototype lead designs and perform preliminary bench top testing
  • Develop processes for advanced lead designs
  • Develop, document, and implement test protocols for design verification and process validations
  • Design tooling for manufacture and assembly of implantable leads
  • Support in vivo and clinical evaluation of developed components

 

EMBEDDED SOFTWARE/FIRMWARE ENGINEER FOR MEDICAL DEVICES – Austin, TX or San Jose, CA

Requires: BS in Electrical or Software Engineering & 5+ years exp designing & developing embedded systems for medical devices; expertise in embedded C/C++, in optimization for performance & memory usage; exp developing apps that run a variety of OS/RTOS targets; working in structured environment w/ source control & bug tracking systems; exp developing low level device drivers for SPI, I2C, USB, LCD, ADC, DAC, exp with variety of CPU architectures (Arm Cortex M3/M4, TI MSP430 etc.; exp w/ board bring-up; effective use of hardware test equipment including logic analyzers, digital storage oscilloscopes, etc. Requires proficiency with Microsoft Office tools.

Responsibilities:
* Develop firmware for very low-power, battery powered systems consisting of a mix of analog, digital & RF circuitry in highly integrated, low power embedded designs
* Participate in design activities at architectural & implementation levels
* Design & implement error checking & fault handling, robustness & safety features
* Document software design & implementation
* Support V&V testing, work with V&V team to develop test plans & protocols
* Adhere to standards to help ensure compliance with FDA, ISO, AAMI & UL standards.

Director, Quality Assurance – Mt. Laurel, NJ
In the process of getting filled. 

 

Requirements include: Bachelors degree; 10-12 years experience in QA including medical device industry experience and supervisory/ management experience; & Good working knowledge of domestic & international requirements & regulations such as FDA, ISO, GMP etc.

Tasks:
* Work with contract manufacturer to ensure that devices are manufactured in compliance with US and international quality system requirements.
* Participate in product development teams on behalf of Quality Systems. Identify and resolve quality issues throughout product development process to assure successful audits and regulatory filings.
* Review all product complaints and ensure timely reporting of those events to domestic and international regulatory agencies as necessary.
* Schedule, conduct and assist in responding to internal audits , supplier audits and inspections.
* Maintain a functional CAPA system in compliance with applicable regulations
* Maintain ISO 13485:2003 facility registration in accordance with applicable standards.
* Provide guidance and supervision for Shipping/Receiving Clerk as it relates to completion of receiving inspections and other quality related functions.
* Ensure that the Quality Systems function is carried out in accordance with GMP and ISO directives.
* Review and revise quality system documentation to ensure compliance with domestic and international quality and regulatory requirements.
* Manage, supervise and train staff, oversee projects ongoing within departments, carry out departmental administrative duties.
* Schedule and complete timely management review presentations.
* Manage the document services function to ensure that quality systems documents, records and regulatory submissions are controlled.
* Manage product release and non-conforming product activities
* Maintain program to ensure adequate training of personnel on quality system documentation. Work with HR Department on companywide training activities.
* Ensure employees training on the Quality Systems Regulation and key international regulations and standards.
* Manage the program for handling product returns, returned product evaluations (and repair/rework, where applicable), complaints and customer feedback in accordance with internal policies and procedures.

Senior Clinical Research Monitor: Located anywhere (requires 80% travel)

Position Summary: Responsible for data quality & regulatory compliance at US clinical trial investigational sites. This responsibility is carried out by conducting on-site monitoring visits with Investigator & other research personnel.  Highly competitive salary.

Primary Responsibilities
* Orient site personnel to study protocol/procedures
* Monitor compliance to FDA Regulations & study protocol
* Monitor & promote compliance to local IRB reporting regulations
* Manage study site activities through frequent on-site visits
* Perform initial, interim & closeout study visits
* Communicate findings to investigators & study staff at the site
* Prompt reporting of compliance issues to in-house staff
* Follow-up on all outstanding issues to ensure each matter is addressed in a timely fashion
* Provide timely communication & written reports to the Clinical Affairs department after each monitoring visit

Additional Responsibilities
* Schedule on-site monitoring activities & travel in conjunction with company travel policies.
* May be required to supervise additional field monitors
* Up to 80% travel required.

Education and Experience Requirements
* This position requires a RN, BS, or similar degree (CRCC) with at least 5 years experience in monitoring clinical studies. The candidate must be very familiar with all FDA regulations governing IDE clinical trials.
* Experience in cardiac medical device related clinical trials
* Experience in clinical trial data management

Field Clinical Engineer (FCE) – Germany ( several locations: North Bavaria and Thüringen)

Requirements: BS in Engineering, Science or related; 5+years experience with use of invasive cardiovascular medical devices; knowledge of device-based cardiac rhythm & heart failure management; Prior experience working with clinical studies; Ability to quickly analyze & resolve clinical/technical issues; Frequent traveling to investigational sites, corporate offices, investigator meetings &  industry meetings.

Tasks:
* Develop a strong rapport with clinical sites by acting as consultants to support the site’s needs.
* Responsible for supporting all field-based activities at clinical sites.
* Drive enrollment by ensuring that investigational sites receive the necessary support in order to enroll, implant, and follow patients in a manner consistent with the clinical protocol.
* Support implant procedures and follow-ups at clinical sites
* Share clinical / technical experiences with other personnel in order to improve understanding of product behavior, improve product performance and product acceptance by customer.
* Communicate activities and issues at clinical sites with other company personnel
* Fulfill all administrative requirements including the collection of relevant technical data and completion of necessary documentation

Senior Electrical Engineer – Mt. Laurel, NJ – may be filled soon

An innovative medical device company focused on treatment of cardiac diseases, has an exciting opening for Senior Electrical Engineer in Mount Laurel, New Jersey.

Requirements: B.S. in EE; 5+ years experience as R&D EE in regulated industries (i.e Medical, defense, etc.); Applications development & PM experience; exp writing protocols, reports, regulatory documents; Understanding of patent applications & processes.  Exp in circuit design (Analog & mixed-mode circuits) & with digital signal processing algorithms, a big plus.

Tasks:
* Provide project leadership in product design & specifications, under direction of VP Product Development.
* Develop reliability tests programs &  setups to implement test protocols
* Work closely with vendors (i.e design subcontractors) on product requirements & specifications.
* Conduct design reviews & ensure compliance of design regulations including QSR, ISO standards and corporate policies.

Leave a comment

Role of IP Due Diligence in Corporate Finance


A panel moderated by Jim Hesling, at Wilson Sonsini Medical Device Conference, with Eric Bell from Spring Rock Ventures, Mir Imran from Incube Ventures, and Gwen Watanabe from Teleflex, discussed the role of IP due diligence in corporate finance.  The panel offered great advice and insights for medtech startups.

From the buy side perspective, InCube Ventures invests in mid to late stage companies and focuses specifically on disruptive innovations that change patients outcomes, said Imran.  While their focus area may be in white space of IP, depending on the technology, Incube does thorough investigation of IP, said Imran.  Also early on they assess if it is incremental innovation of existing solution or a truly disruptive concept.

Also from buy perspective, Watanabe said, during the acquisition process, they like to see entire application, talk with the team and then do complete due diligence on the patent portfolio.  Watanabe said when buying “we also deconstruct claims for validity”.  She added, “we don’t stop at patents, IP also includes grants, know hows, and any other secrets”.  Teleflex also uses software tools to map out the IP area and it operates in 160 countries. They have an external counsel going through the FTO and they pay specific attention to any potential for patent infringement.  Eric Bell from Springrock Ventures, said, they use external counsel to do thorough assessment and clearly consider issued patents versus filed patents, because when issued it provides contextual validity.

Speaking from the sell side perspective, Imran offered lot of great advice to the entrepreneurs. Imran is a serial entrepreneur with several successful companies, and advised that entrepreneur hire a litigator to review their patent portfolio to point out holes and weaknesses as well as areas of strength.  A litigator can have a vastly different perspective than a prosecutor, said Imran.  Both Bell and Imran also suggested that entrepreneurs continue to focus on the IP as the technology moves forward.  Many founders focus strongly on IP earlier and specially when fundraising but then put it on the back burner.  However, as direction changes occur, they become lax on IP and it may not allow for product to be fully covered and it can impact subsequent fundraising.  Also the patent landscape is too crowded and freedom to operate is very important, said Imran.

Panelists asserted that while ongoing IP commitment is extremely important, they agreed that IP alone does not create value.  Real value is created from total context including patient outcomes, regulatory approvals, reimbursement etc.  Some young CEOs do a press release when a patent is filed or approved and Imran advised, they not do it and Watanabe chimed in that they do it when they get FDA approval.  “One thing I do is to step back and think about how I would get around my own patents and then file more patents, so I think like a competitor”, said Imran, himself a holder of hundreds of patents.  Imran said, while patent filings are very expensive and companies can’t do it frivolously, he also suggested that companies file patents in other countries with substantial markets like India and China.  Founder should formalize the process internally in the company so that employees are keeping good lab notebooks and everything is documented to be able to defend obviousness claim, said Imran.  

PS – Please check out exciting jobs offering opportunities to work with disruptive technologies in JOBS category on this blog & please send leads or resume at wd_darshana at hot mail dot com.

Leave a comment

New Corporate Deal Models for Medtech Companies


Often continuous internal innovation is expensive and unpredictable for medtech companies, and yet in order to continue to grow their business, they need to introduce important new products.  A panel at 2016 WSGR Medical Device Conference, discussed what large companies are looking for today and how evolving deal structures can benefit both the buyer and the seller.  The panelists discussed this in context of their own stories of deal models.  On the panel moderated by Steve Levin,  were Fred Aslan from Adavium Medical, Hanson Gifford from The Foundry, Bruce Roberts from RM Global Partners, and Thierry Thaure from Cephea Valve Technology.  

Thaure discussed Abbott’s interest in Cephea and how the milestone based deal was struck.  Mitral valve disease is highly complex and requires multiple treatment options.  Abbott’s interest in Cephea emerged from the objective to complement its own portfolio of mitral valve replacement therapies.  Cephea’s catheter based mitral valve replacement therapy seemed to fit in nicely with Abbott’s Mitraclip device, for addressing this huge market opportunity.  Initially, Abbott made an equity investment, holding the option to acquire.

The Foundry built by a group of serial entrepreneurs, do a lot of inventing but additionally also look at other outside opportunities that address dramatic clinical improvement over existing treatment models.  Thus operating as a medical device incubator, The Foundry helps the companies it takes under its wings, with fundraising, recruitment and helps them to rapidly transform their concepts into companies.  Since its inception in 1998, The Foundry has founded and financed nearly a dozen medical device companies which have generated over $2 billion of value.  Ardian came out of the Foundry and was acquired in cash plus commercial milestones based deal by Medtronic.  Foundry’s some of the other successes include Cabochon Aesthetics (acquired by Ulthera), Concentric Medical (acquired by Stryker), Emphasys Medical (sold to Pulmonx), and evalve (acquired by Abbott).

Fred Aslan said while countries like Brazil, China, and India offer huge growth opportunities, navigating those markets to develop sales and marketing is very challenging as these are highly fragmented markets with mom and pop establishments and while companies should work with local distributors, it is also hard to find distributors.  With two recent acquisitions, Advium transformed itself into the largest Brazilian medical equipment and diagnostics company as measured by sales and number of customers across both specialties.  Brazil is one of the most complex and one of the largest healthcare markets in the world, after US and China.  Aligning with the needs of the market, Advium focuses heavily on aesthetics, dermatology, plastics surgery, vascular surgery, and gynecology and on clinical diagnostics.

As a senior partner, Roberts oversees the medtech M&A practice at RM Global Partners LLC, boutique investment banking and strategic advisory firm.    “Every technology we help develop is some form of global technology arbitrage”, said Roberts.  RMG helps increase the value of their clients’ innovation pipeline while helping them account for risk and uncertainty.  Besides financial and strategic advice to its clients, RMG leverages its global network to source and execute transactions to build new opportunities for their clients, worldwide.

PS – Please check out exciting jobs offering opportunities to work with disruptive technologies in JOBS category on this blog or at link http://bit.ly/28J800w & please send leads or resume at wd_darshana at hot mail dot com.

1 Comment

Medtech Emerging Models of Innovation – WSGR 2016 Medtech Conference


A breakout panel at recent Wilson Sonsini Medical Device Conference, with Scott Murano from Wilson Sonsini, Fred Toney from Lean Launchpad, Kevin Wasserstein from Neurotechnology Innovations Translator, and Ryan McGuinness from Triple Ring Tech, discussed new emerging models of innovation for medical technologies.  The panelists shared the methods they use to identify important new innovations, and how they assist in rapidly building product prototypes and help complete first-in-man cases in a cost effective manner.  

Toney, at Lean Launchpad (that was started by Steve Blank), said they cast a wide net and take several contenders through a stringent vetting process and make a final selection to invest in 6-10 companies, with fundable milestones, and clear clinical evidence.  These companies are fostered from early stage and provided guidance, teaching, and tools to understand customers in a deep way.  

At Triple Ring, the driver is to create opportunities for serendipitous events and help create a robust ecosystem and build upon the opportunities that come through the network, said McGuinness.  This model thrives best in Silicon Valley, with an existing thriving ecosystem, though they are trying to export the model to other parts of the country.  The companies are vetted through the expertise of Triple Ring staff in their specific domains.  Triple Ring invests in a small subset of companies that are incubated there but it is not a requirement of participating in the incubator.  More importantly, TRT supports interesting projects or companies with its world class R&D capability.  The focus at TRT is to move quickly to add value and reach the inflection points/ funding milestones.  When data indicates non viability of the idea, “we move quickly and kill easily and cheaply, adding value to the fail fast side of the coin”, said McGuinness.  

Neurotechnology Innovations Translator, that has come out of Ohio State, is not a VC firm but assists medtech companies by providing comprehensive clinic development resources, management and leadership expertise and helping raise investment capital.  In vetting process, Wasserstein said they look for the size of the clinical need the technology seeks to address and the market opportunity it represents.  Starting with some objective criteria, they overlay that with how the company can truly make an impact and how well it would thrive with the ecosystem they can  provide, said Wasserstein.  The Translator has access to excellent advisors, animal lab and engineers on bench for rapid testing, and onsite rapid prototyping facility to move projects forward quickly.

The panel agreed that medtech investing is not dead but companies need to stay focused on solving a problem and have the tenacity, persistence and creativity and look for out of the box resources to help them move forward.

 PS – Please check out exciting jobs offering opportunities to work with disruptive technologies in JOBS category on this blog & please send leads or resume at wd_darshana at hot mail dot com.

,

Leave a comment

2016 Wilson Sonsini Medical Device Conference Synopsis


 

2016 Wilson Sonsini Medical Device Conference took place in San Francisco.  While the tone of the conference was upbeat, there was also an acknowledgement of the challenges that medtech companies continue to face.  New and innovative models are emerging to help navigate medtech companies through the challenging landscape.

Considerable discussion focused around monetary challenges.  The conference started with a spotlight on venture capital with two new funds investing in early stage medical technology companies.  Given the shrinking pool of investors interested in medtech companies, it was uplifting to hear from Sante Ventures and Apple Tree Partners about their focus on early stage medtech companies.

Breakout sessions focused on a range of topics that would help them steer a startup through building it and taking it from concept to commercialization, in a cost effective manner.  A panel discussed emerging new methods of innovation to help the company through early prototypes and early first-in-man cases speedily.  Obtaining reimbursement in the changing healthcare system is one of the most significant challenges and a panel addressed the issue of the reimbursement puzzle and ways to accelerate the adoption of new but unreimbursed medical devices.  One panel focused on ways of creating win-win transactions with corporate investors, whereas another focused on new corporate deal models.   

New methods of innovation increasingly include partnerships and collaborations with players outside the US.  With growing interest from Japan in investing in US medtech companies, Japan has emerged as an important partners.  A panel of experts discussed ways in which Japan and Silicon Valley startups are collaborating to finance and develop advanced medical technologies.  Panels also discussed topics like Asian funding strategies and Israeli medtech revolution.  

There were also discussions around more specific technologies and topics.  Topics like off-label promotion and hiring and compensating CEOs were also discussed.  A panel of CEOs with success in launching new products and building sales organizations, discussed evolving commercialization strategies required for product adoption.  One panel focused specifically on the future of innovation in the area of percutaneous valve products that has recently revolutionized the heart valve market.  Another panel discussed IPOs and corporate buyouts and in yet another panel the focus was on role of IP due diligence in corporate finance.

Before the corks came off the wine bottles, with venture capitalists serving as sommeliers, the semi finalists chosen for MedTech Innovator award were spotlighted.  From 430 companies that presented their pitch to a panel of judges (a 30% increase from 2015), 20 semi finalists were selected to present a one minute pitch in a video.  The audience heard their pitch in a 20 minute video.  From these, four were selected to present longer pitchs and answer questions posed by a panel of judges.  The audience then voted to select one of these four and the winner received a $25,000 award.   By then it was time to uncork the wine and get better acquainted with those who poured the wine and who might pour much needed cash into medtech startups.

I will post a few different blogs on some of the panels, over the next few days.  So stay tuned.  Below are some highlights from venture capital spotlight discussion that started the morning.

Venture Capital Spotlight

The Conference opened with a spotlight on venture capital, in a panel moderated by David Cassak in conversation with Joe Cunningham from Sante Ventures and David McIntyre from Apple Tree Partners in discussion with David Cassak.  Sante Ventures and Apple Tree Partners are two new funds that are actively investing in early stage medtech.

Sante Ventures go in typically at Series A round and are generally first institutional investor, said Cunningham.  David McIntyre said that he does not find two areas appealing, digital health and diagnostics, more so because he does not have deep background in investing in digital health; but things are moving in that direction and they have looked at some wearables.  Cunningham also said, “We have done more medtech than IT, and when we look at digital health, we look for profound changes”.

Emphasizing the importance of cost cutting in healthcare, Cunningham said, “if you go out on the street and ask people about the brand of hip or knee replacement they favor, they couldn’t tell you; in healthcare it is not so much about the brand, but the cost”.

PS – Please check out exciting jobs offering opportunities to work with disruptive technologies in JOBS category on this blog & please send leads or resume at wd_darshana at hot mail dot com.

Leave a comment

Individualism and America’s love affair with guns – make America safe again


Individualism and self reliance are deeply rooted values in America and these are wonderful values.  Women like me who come to the US from a more traditional, paternalistic culture, find opportunities to excel, and appreciation of their individual worth in this culture.  However, this deep rooted individualistic perspective also impacts lax gun laws, in this country.  

Americans contend that they want to feel secure INSIDE their homes and therefore they favor legal gun ownership.  Who are the people sitting inside the homes, homes that are attractive to intruders?  Most likely they are older people of some means or sometimes they are people living in good neighborhoods keeping a watch that no one wearing a hoodie ambles into their space.  Who are the people who are out and about, are in schools, colleges, in shopping malls, movie theaters, and clubs?  Often these are young people. (http://bit.ly/QZOh2a,  http://bit.ly/TlaQN2) And sometimes they are people of lesser means in wrong clothes, in wrong neighborhoods http://bit.ly/15EInJ4 .   No parent will knowingly want to arm themselves to be more secure while their children are running around exposed to threats outside, and yet that is exactly the effect created.  As we arm ourselves to create security in our small living spaces, we forget where our loved ones are; our individualistic perspective only enables us to see that if we are armed then we can defend our loved ones.  We want to control our fate and that of our loved one.  We forget that fewer intruders now attempt to break into increasingly more secure homes; more enter through open windows or doors.  While we don’t need guns to protect ourselves in our homes, with lax gun laws, more people heavily armed, seek out crowded places where young innocent people are studying, mingling, shopping, enjoying a movie, finding love.

During intense discussion and postmortem on the news channels, after the Orlando shooting, I watched with fascination, the overwhelming interest in analysis, re-analysis, post analysis and continuous repetition about the life and actions of the individual shooter, Omar Mateen. I understand that the law enforcement would be interested in such analysis in order to ensure that attacks like these may be prevented in future, and in order to bring any other accomplices to justice.  But why should the public hear for the umpteenth time what the shooter texted to his wife and what his father thought of the attacks?  Does it come from a false illusion of safety that if we would only understand fully this individual attacker then we can prevent other attackers, despite even law enforcement people saying over and over that it is very hard to stop lone attackers, with semi automatic weapons?

Even when it is clearly evident that we have no control, we assume control.  Ironically, Donald Trump tweeted “Appreciate the congrats for being right on radical Islamic terrorism”.  Trump has insisted on using the phrase “radical Islam” and sure we must acknowledge radical elements responsible for the attacks, but then why not use a more appropriate term “radical ideology” so that we can understand a broader range of mass shooters including those like Mateen but also those like Boston marathon bombers, the Tsarnaev brothers and Wade Michael Page, the white supremacist who engaged in the Sikh temple massacre?  And should we also invent a term for those with guns, with mental illness, like Adam Lanza (Sandy Hook shooter), James Holmes (Aurora, CO shooter), and Seung-Hui Cho responsible for the Virginia Tech massacre; people who should get easy access to health care, not easy access to guns.  Also, Orlando shooter, Mateen like Sandy Hook shooter, Lanza, grew up in the US.  For how many generations are we going to consider people to be immigrants, when many young people are easily acquiring radical ideology vastly different from the environment they grew up in?  Consider also the information below that may be contradictory to many of our tightly held beliefs. While two young girls in Erbil, invented a fast bomb detection system to counter terrorism threat http://rudaw.net/english/kurdistan/280620141 , some young people having grown up in Christian homes in the US and Europe have been attracted to join ISIS. The threat my friends, comes from any extremist ideology that can target our disillusioned youth. 

In the age where world is getting smaller, in an age where people leave their homeland by boatloads and risk their lives to escape their grim realities, in an age of extensive air travel (because more illegal immigrants in the US, enter legally), in the age of fence jumping, drones and tunnels, we want to resort to the primitive; and build walls, because we believe in creating our small safe zone domain.  In an era where Chinese hackers can get into our military databases, where hackers from Nigeria can steal our credit card details, ISIS can steal the souls of our young people through social media, and engineers from Brazil, China and India can steal our jobs, without stepping foot on the US soil; in an era where boundaries are getting extended or disappearing altogether, we wish to create security by building a wall, that gets bigger on a whim. (Unfortunately Great Britain’s vote to exit the EU this morning, is along the same lines).

And finally, there is no case for increasing the safety against home intruders with a semi automatic rifle versus a handgun.  The design of first semi automatic rifle is attributed to a German gunsmith in the year 1885.  The second amendment was adopted in the year, 1791.  Clearly the second amendment does not pertain to semi automatic weapons; it only pertains to the right of the people to keep and bear arms, supporting the natural rights of self-defense; not to support unnatural obsession for annihilation of others.

Once again in conclusion, guns give us a false sense of security, but enhance the real danger of unintended and innocent victims, often younger in age.  According to some recent stats on gunviolencearchive.org, the number of people killed in home invasion incidents is smaller than number of people killed accidently, and each of these numbers were higher almost by 10X than the number of people killed in mass shootings.  Most deaths in the US by gun violence happen in ways we don’t read about in a newspaper; and all of these shooting incidents have only one thing in common, typically a gun is involved.

If we wish to take collectivist responsibility for safety of all citizens versus creating tiny islands of assumed safety in our homes, then we must pass sensible #gunreform laws to institute background safety laws. But remember, this is a small and partial measure.  People with mental illness or disillusioned kids falling through the cracks become temporarily more radical in teen and young adulthood years; at this point they many not have any established patterns of behavior.  We must ban semi automatic weapons; no civilian needs to own them.  We must create a safety net for our children during impressionable years, so we don’t lose them to radical elements.  We must make mental health easy and available for anyone who seeks it.  Pacifists like me must work with law abiding gun owners who also favor sensible gun laws, while protecting the 2nd amendment.  Let us take a collectivist stand to support leaders who are actively speaking out with our voice, our votes, and money so that our children can be free to learn and give those stealing their jobs, a run for their money; so that they can go to the movies and shopping malls, without fear; so that they feel free to find love, because love always triumphs hate.  Let us think beyond creating our small island of safety, and build a safer country for our children and for future generations.

 

 

Leave a comment

JOBS – June, 2016


All US based opportunities require valid US work visa and prior experience in biomedical industry.  Most of my current needs are in engineering and all engineering opportunities require medical device experience.  I have added some other opportunities in science, sales, BD etc.

I will be adding more opportunities.  If interested in any opportunities below, please send me an email (resume as an attachment) at wd_darshana at hot mail dot com and include position title in the subject line.  Please include in the email, how well the description matches your background and where the gaps are, if any.  All leads or referrals are greatly appreciated.

Director of Engineering – San Jose, CA
(Medical device implantable experience and hands-on engineering passion required).

Automatic Test Equipment Engineer – San Jose, CA
Immediately available.  Requires medical device experience. Send in resume ASAP.

Manufacturing Quality Engineer – San Jose, CA
Immediately available. Please send in resume ASAP.

Biochemist – San Jose, CA
Requires MS with 6+ years experience or PhD with 3 years experience in Biochem, Molecular Biology or related.  Immediately available, send in resume ASAP, if interested.

Quality Assurance Manager – San Jose, CA


Senior Manufacturing Engineer – San Jose, CA


Manufacturing Technician – San Jose, CA


Senior Mechanical Engineer – San Jose, CA

Biologist – San Jose, CA
Software Sales – San Jose, CA
Seed stage company offering a suite of subscription based software products, supported by cloud infrastructure, has an exciting opportunity for software sales professional, to join as member of the core founding team.  Although at pre-funding stage, the company is already generating revenues, with massive and growing database of products that can help scientists make environmentally friendly decisions throughout product development life-cycle.  Extensive customer relationship experience is required.  Familiarity with SciFinder, Reaxys etc. is required.   

Engineering Technician – Mt. Laurel, NJ

An innovative medical device company focused on treatment of cardiac diseases, has an exciting opening for Engineering Technician, in Mount Laurel, New Jersey.

Requirements: BS in EE, 3+ years experience as R&D Electrical Engineering Tech/ Testing Engineer, Prior experience in strongly regulated industries (e.g. medical, defense etc.), Prior experience with reliability tests and assembly.

Job functions:
* Conduct all assigned tests, under the direction of a senior engineer.
* Implement reliability test programs and test setups to implement test protocols.
* Conduct and document test protocols in component and system reliability, failure analysis, etc.
* Ensure compliance with regulations including QSR, ISO Standards and corporate policies.
* Specify and purchase components for test setups and prototypes.
* Procure and maintain engineering lab equipment in accordance with quality practices.

Senior Business Development Role – EU

Reporting To: Head – Global BD to manage all aspects of business development across the CRO portfolio of services; secure and retain business through professional, consultative & proactive sales activities directed at key decision makers.

Responsibilities:
Maintain knowledge of all appropriate cross-sell opportunities; Continued awareness of competitive activities, positioning & pricing; Work with regional & international counterparts to develop & close integrated opportunities; Analyze potential opportunities & develop sales plans for each target account; Develop in-depth knowledge of customer organization; Represent company at various industry conferences & trade shows; Prepare & lead sales presentation; Educate team in customer culture, operational needs/methods & sales techniques; Handle follow-up related to sale & drive completion of contract;  Maintain high visibility in customer organization; Monitor customer satisfaction; Record, plan & coordinate customer sales activities in CRM (SALESFORCE) system.

Requirements:  BS or MS in Life Sciences – PhD. preferred; 10+ yrs experience in BD / sales for CRO, CMO or related in life sciences; Ideally industry experience in combination of pharma or biotech in discovery research, CMC or commercial manufacturing technical roles; Solid understanding of drug discovery & development process; Track record of achievement in terms of sales goals; Experience working with international clients & colleagues; Ability to visualize & integrate company’s service portfolio across the drug development continuum;  Ability to cross-sell & credibly represent company services to clients; Ability to work from home-based office

Additional details: The position is located in EU.  Base pay: between 100,000 to 125,000 euros, car: 800 euros per month, VPP: 5% of base pay; Pension benefits: as applicable per country, Designation – Regional Director, BD

Analog Design & Embedded Systems Engineering Leader – San Jose, CA

Innovative, well funded bio-medical startup with disruptive technology has an exciting opportunity for analog design engineering leader, in San Jose, CA. Stock options, in addition to working on something truly exciting and life changing, would be a huge upside in this opportunity.  Requirements include, years of steady experience and passion for engineering problem solving, natural ability to take leadership role (MBA not required). This opportunity is immediately available and if you are engineering problem solver then it is one of the most exciting opportunities you may come across.  

Leads Engineer – Austin, TX or San Jose, CA

Requires BS in mechanical engineering, related to biomedical engineering and 10+ years medical device experience.  Highly desired, experience designing and developing medical products with implantable leads like cardiac pacemaker leads, proficiency in CAD, SolidWorks, and experience with MatLab, hands-on experience for fabricating prototype leads and related fixtures and tooling.

Responsibilities:   

  • Design and develop new conceptual leads in groundbreaking fields of medical devices.
  • Prototype lead designs and perform preliminary bench top testing
  • Develop processes for advanced lead designs
  • Develop, document, and implement test protocols for design verification and process validations
  • Design tooling for manufacture and assembly of implantable leads
  • Support in vivo and clinical evaluation of developed components

 

EMBEDDED SOFTWARE/FIRMWARE ENGINEER FOR MEDICAL DEVICES – Austin, TX or San Jose, CA

Requires: BS in Electrical or Software Engineering & 5+ years exp designing & developing embedded systems for medical devices; expertise in embedded C/C++, in optimization for performance & memory usage; exp developing apps that run a variety of OS/RTOS targets; working in structured environment w/ source control & bug tracking systems; exp developing low level device drivers for SPI, I2C, USB, LCD, ADC, DAC, exp with variety of CPU architectures (Arm Cortex M3/M4, TI MSP430 etc.; exp w/ board bring-up; effective use of hardware test equipment including logic analyzers, digital storage oscilloscopes, etc. Requires proficiency with Microsoft Office tools.

Responsibilities:
* Develop firmware for very low-power, battery powered systems consisting of a mix of analog, digital & RF circuitry in highly integrated, low power embedded designs
* Participate in design activities at architectural & implementation levels
* Design & implement error checking & fault handling, robustness & safety features
* Document software design & implementation
* Support V&V testing, work with V&V team to develop test plans & protocols
* Adhere to standards to help ensure compliance with FDA, ISO, AAMI & UL standards.

Director, Quality Assurance – Mt. Laurel, NJ
In the process of getting filled. 

 

Requirements include: Bachelors degree; 10-12 years experience in QA including medical device industry experience and supervisory/ management experience; & Good working knowledge of domestic & international requirements & regulations such as FDA, ISO, GMP etc.

Tasks:
* Work with contract manufacturer to ensure that devices are manufactured in compliance with US and international quality system requirements.
* Participate in product development teams on behalf of Quality Systems. Identify and resolve quality issues throughout product development process to assure successful audits and regulatory filings.
* Review all product complaints and ensure timely reporting of those events to domestic and international regulatory agencies as necessary.
* Schedule, conduct and assist in responding to internal audits , supplier audits and inspections.
* Maintain a functional CAPA system in compliance with applicable regulations
* Maintain ISO 13485:2003 facility registration in accordance with applicable standards.
* Provide guidance and supervision for Shipping/Receiving Clerk as it relates to completion of receiving inspections and other quality related functions.
* Ensure that the Quality Systems function is carried out in accordance with GMP and ISO directives.
* Review and revise quality system documentation to ensure compliance with domestic and international quality and regulatory requirements.
* Manage, supervise and train staff, oversee projects ongoing within departments, carry out departmental administrative duties.
* Schedule and complete timely management review presentations.
* Manage the document services function to ensure that quality systems documents, records and regulatory submissions are controlled.
* Manage product release and non-conforming product activities
* Maintain program to ensure adequate training of personnel on quality system documentation. Work with HR Department on companywide training activities.
* Ensure employees training on the Quality Systems Regulation and key international regulations and standards.
* Manage the program for handling product returns, returned product evaluations (and repair/rework, where applicable), complaints and customer feedback in accordance with internal policies and procedures.

Senior Clinical Research Monitor: Located anywhere (requires 80% travel)

Position Summary: Responsible for data quality & regulatory compliance at US clinical trial investigational sites. This responsibility is carried out by conducting on-site monitoring visits with Investigator & other research personnel.  Highly competitive salary.

Primary Responsibilities
* Orient site personnel to study protocol/procedures
* Monitor compliance to FDA Regulations & study protocol
* Monitor & promote compliance to local IRB reporting regulations
* Manage study site activities through frequent on-site visits
* Perform initial, interim & closeout study visits
* Communicate findings to investigators & study staff at the site
* Prompt reporting of compliance issues to in-house staff
* Follow-up on all outstanding issues to ensure each matter is addressed in a timely fashion
* Provide timely communication & written reports to the Clinical Affairs department after each monitoring visit

Additional Responsibilities
* Schedule on-site monitoring activities & travel in conjunction with company travel policies.
* May be required to supervise additional field monitors
* Up to 80% travel required.

Education and Experience Requirements
* This position requires a RN, BS, or similar degree (CRCC) with at least 5 years experience in monitoring clinical studies. The candidate must be very familiar with all FDA regulations governing IDE clinical trials.
* Experience in cardiac medical device related clinical trials
* Experience in clinical trial data management

Field Clinical Engineer (FCE) – Germany ( several locations: North Bavaria and Thüringen)

Requirements: BS in Engineering, Science or related; 5+years experience with use of invasive cardiovascular medical devices; knowledge of device-based cardiac rhythm & heart failure management; Prior experience working with clinical studies; Ability to quickly analyze & resolve clinical/technical issues; Frequent traveling to investigational sites, corporate offices, investigator meetings &  industry meetings.

Tasks:
* Develop a strong rapport with clinical sites by acting as consultants to support the site’s needs.
* Responsible for supporting all field-based activities at clinical sites.
* Drive enrollment by ensuring that investigational sites receive the necessary support in order to enroll, implant, and follow patients in a manner consistent with the clinical protocol.
* Support implant procedures and follow-ups at clinical sites
* Share clinical / technical experiences with other personnel in order to improve understanding of product behavior, improve product performance and product acceptance by customer.
* Communicate activities and issues at clinical sites with other company personnel
* Fulfill all administrative requirements including the collection of relevant technical data and completion of necessary documentation

Senior Electrical Engineer – Mt. Laurel, NJ – may be filled soon

An innovative medical device company focused on treatment of cardiac diseases, has an exciting opening for Senior Electrical Engineer in Mount Laurel, New Jersey.

Requirements: B.S. in EE; 5+ years experience as R&D EE in regulated industries (i.e Medical, defense, etc.); Applications development & PM experience; exp writing protocols, reports, regulatory documents; Understanding of patent applications & processes.  Exp in circuit design (Analog & mixed-mode circuits) & with digital signal processing algorithms, a big plus.

Tasks:
* Provide project leadership in product design & specifications, under direction of VP Product Development.
* Develop reliability tests programs &  setups to implement test protocols
* Work closely with vendors (i.e design subcontractors) on product requirements & specifications.
* Conduct design reviews & ensure compliance of design regulations including QSR, ISO standards and corporate policies.

, , , , , , , , , , , , , , ,

Leave a comment

The Wild Party – Play Review


 

Andrew Lippa’s Off-Broadway musical sensation, based on the poem by Joseph Moncure March, currently being played at San Jose Stage, tells the story of Queenie (Allison F. Rich) and Burrs (Noel Anthony).  Directed by David Davalos, with music direction by Lauren Bevilacqua, The Wild Party captures the reckless tale of pleasure seeking and decadence that characterized the “roaring 20s”, an age of bootleggers, flappers, talkies, and organized crime.

Prohibition!
They can shove it.
Revolution!
Rise above it.
My solution:
Time to covet
Love it before it’s too late.

A cast of colorful characters gather for a night of sex, drugs, and all that jazz, at the home of Queenie and Burrs.  “Queenie was a blonde and her age stood still…….Her legs were meant to drive men mad, and she did”.  The cruelty and meanness in Burrs attracted Quennie at first but after three years, life became boring; spark was gone but meanness remained.  To reignite the passion, she organizes a party, a wild party!  “What a night.  Cool Paradise turned hot!  We were having a wild, wild party.

Queenie and Burrs, the stars of Vaudeville, invited Madeline (Theresa Anne Swain) the lesbian, Mae (Allison Parker) the dimwit, Eddie (Mike Birr) the thug, Jackie (Noelani Neal) the dancer, Dolores (Adrienne Herro) the hooker, Oscar and Phil D’Armano (Keith Pinto and Jake Mahler) the gay lover brothers, and Nadine (Brittney Monroe) the minor.

Burrs and Queenie are conflicted lovers.  Burrs soon abandons gorgeous Queenie and makes the moves on the minor guest, Nadine. Queenie reprimands him and then seeks to ignite the spark with the number below.

Lock the door and stop complaining
Gather ’round and listen well
From now on we’re entertaining
How to hotten up this hell.
Hold your mood and hold your bladder
Skip the food and stop the chatter
Can’t you hear the pitter-patter?
We’re not here to eat.
We came for the heat!
Let’s raise the roof
Let’s make a scene
Let’s hop the gods of love
Will shine above
And show the way.

Her prayers are answered and soon they are joined by vivacious Kate (Courtney Hatcher) with her new friend Mr. Black (C J Blankenship).  Queenie is taken aback by the charm and kind attentions of Mr. Black, and throughout the party her feeling for Mr. Black continue to grow, as Burrs is now going green with envy, and is getting obsessed with re-owning Queenie.

Why do I need her so much?
This woman makes me cry
This woman makes me burn
This woman’s eye can cut me to the core

Mr. Black falls in love with Queenie as his sympathy for her plight grows and he wants Queenie to go away with him.

Poor child,
Poor child,
Beautiful and bruised.
Poor child,
Pure child,
Virginal and used.

And

What is it about her
That makes me want her?
What is it about her
That turns me pale?
Something in her smile
Something that I’ll never understand
Her wild abandon.

Queenie is also very conflicted.  On one hand she feels incapable of leaving mean and cruel Burrs, but on the other hand she is very much attracted to attentive Mr. Black.  She pours out her heart over her conflicting feelings for Burrs to Mr. Black in the number below.

I know it’s wrong
I know he’s rough
I don’t know what to do
But we’ve been through enough
I know it’s time
And yet I play
Maybe I like it this way.
I see his pain
I hear his cry
He pulls me to the edge
But I don’t ask him why
I understand
And I obey
Maybe I like it this way.

Meanwhile much is going on in the wild party.  Kate tries to seduce Burrs and distract him from his obsession with Queenie; Madeline hits on Nadine who is horrified at first but soon gets in the mood of the party; and others are all engaged in their sexual pursuits and snorting drugs.  Unfortunately, when the end comes, it is neither shocking, nor surprising, and does not feel like a climax, but seems like a natural end to a series of preceding disastrous events.  In many ways, the story feels like a fable where single minded pursuit of simple pleasures leads the participants to a natural and conclusive end.  To that extent, the story lacks the punch.  Also, it is an X rated show, for mature audience only.  And for all the mature content, it fails to deliver a substantial and engaging story line.

However, Randall King is an amazingly talented artistic director and Brett Blankenship and Carmichael “CJ” Blankenship’s choreography is brilliant.  Along with brilliant direction and choreography, the superbly talented cast brings to life the Tony nominated composer and lyricist Lippa’s creation.  If you wish to join “The Wild Party”, the musical will run at The Stage www.thestage.org in San Jose, till July 24, 2016.

 

 

1 Comment

Follow

Get every new post delivered to your Inbox.

Join 3,136 other followers

%d bloggers like this: