Product Characterization - Principal Quality Engineer - Manager Characterization

Title:  Product Characterization - Principal Quality Engineer - Manager Characterization

Location:  Princeton, NJ

The Company:

Stentys is a medical technology start-up company that has developed a novel approach to treat coronary bifurcation disease with a unique drug-eluting, self-expanding stent technology and delivery system. Stentys is looking to develop this unique technology and others in development further to commercialization. With offices in Paris, France and Princeton, NJ, the company aims at launching its product globally.

Stentys is looking to fill various senior and junior level positions in stent, delivery systems and drug elution program development and leadership.

Job Description:

Leading the characterization of the drug eluting stent and delivery system, you will be in charge of all activities related to the in-vitro testing of the Stentys DES and SDS platforms. Ideally, you will hold a BSc or MSc degree in life sciences or engineering with 5-7 years experience in medical device characterization and/or Quality Engineering (stent experience preferred).

Responsibilities include:

· Writing and approving all verification protocols for in-vitro/bench top testing

· Collaborating with engineering and appropriate parties to establish acceptance criteria and tolerances.

· Ensuring product FMEA and risk analyses are completed and well documented following design control requirements.

· Supporting regulatory and clinical filings for EU and US regulatory bodies.

· Performing statistical analyses to ensure product meets acceptance criteria with appropriate confidence level and reliability.

· Identifying, recommending purchase, and managing test lab equipment including maintenance of equipment, validation of test methods and calibrations.

· Performing quality assessments of external vendors.  Responsible for corrective actions for product and processes that are internally or externally driven.

 

The Ideal Candidate Qualifications:

· A BS or MS degree in life sciences/engineering with 4+ years experience in medical device characterization and/or quality engineering (stent highly desirable).

· Experience with establishing quality systems and controls for product reliability and repeatability.

· Strong knowledge of statistical analyses and requirements for product release and regulatory approvals, including manufacturing process controls and indicators.

· Experience in generating protocols and reports acceptable for regulatory filings.

· Experience in risk analyses, FMEA’s, internal and external quality audits.

· Reliability engineering expertise strongly preferred.

· Demonstrated ability to seek and manage external vendors for test method development and product characterization.

 

Personality:
The successful candidate is likely to have the following attributes:

· Results oriented and pragmatic

· Team player yet able to work independently under minimal supervision

· Comfortable with ambiguity and uncertainty

· Knows how to work under time pressure and short deadlines, with ability to multi-task on different levels of responsibilities.

· A true international mindset with an ability to work efficiently across different languages and cultures.

· Enjoys small company culture and atmosphere.

· Excellent verbal and written communication skills

· We offer competitive base salary combined with an attractive stock option plan depending on expertise and seniority level.

 

The Mullings Group has been retained to oversee the recruitment process.

All Resumes should be sent directly to:

Joe@MullingsGroup.com

 

 

 

Key words: Stent  C atheter  Medical Device  Cardiac