Principal Design QA Engineer

Recruiter: Spencer Gregory Hale

Principal Design QA Engineer

About this role:

The Principal Design Quality Assurance Engineer is an experienced professional with wide-ranging experience and expertise in Sustaining quality engineering and New Product Development. The Principal Quality Engineer will develop, establish and maintain quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. 

This is a hybrid position based out of Marlborough, MA with the expectation to be in the office a minimum of two days per week.  

Your responsibilities include:

• Promotes Cross-Functional collaboration and has ability to influence project strategy.  Capable of working independently on highly specialized projects with long range objectives. 
• Leads the execution of Quality Deliverables such as project Design & Development Plans, Design Changes, and Design & Usability Validation Plans. Leads the execution of Risk Management deliverables to ensure compliance to ISO 14971 and demonstrates a primary commitment to patient safety.
• Provide quality and compliance input and coaching for product development and/or post market product sustaining activities, such as design changes, product CE marking, customer complaint investigations, AI requests, NCEP’s and CAPA’s.
• Exercises considerable latitude in determining technical objectives of assignments. Selects methods and techniques to lead a project to completion with focus on translating organizational strategy into tactical deliverables.
• Provides project direction, coaching, and mentoring for engineering and technical team personnel.
• Develops solutions to complex and diverse technical problems which require the regular use of ingenuity and creativity. Exercises judgment within broadly defined practices and policies in selecting methods, specialized techniques, and evaluation criteria for obtaining results.
• Proactively investigates, identifies, and implements best-in-class Quality Engineering practices. Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Supports internal and external regulatory audits.
• Provides technical leadership to business units. Advises management on potential improvements or enhancement to quality systems and processes.
• Support development, implementation and training of corporate quality initiatives. 

What we’re looking for in you:

Minimum Qualification

• BS in Biomedical, Mechanical Engineering or related degree.
• Minimum of 8 years of medical device engineering experience.
• In depth familiarity with the FDA, ISO, MDD, EU MDR and the medical device industry quality requirements associated with product development, design controls, and product risk management.
• Strong communication and presentation skills.
• Solid technical writing skills.
• Travel <10%, if required

 Preferred Qualifications

• 10+ years of medical device engineering experience preferred.
• MS preferred

Requisition ID: 580804

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions.  This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement.  The goal of the drug testing is to increase workplace safety in compliance with the applicable law.  

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.

Boston Scientific maintains a prohibited substance free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status.  Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment.  Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements.   As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.