Senior Design Quality Engineer

Additional Location(s): US-MA-Marlborough; Canada-ON-Mississauga; US-CA-Valencia; US-MN-Arden Hills; US-MN-Maple Grove

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.           

About the role: The Senior Quality Systems Engineer will act as a Subject Matter Expert for the Design Controls and Risk Management spaces within acquisitions, specifically focusing on active implantable and capital equipment products. Responsibilities include product development, remediation, and distribution of acquired products. The engineer will serve as a Global Quality representative leading awareness, visibility, and communication of quality initiatives to support global quality goals, priorities, and compliance in the acquisition and integration space. The engineer will partner with design teams across all divisions to drive and improve our acquisition design strategies, in collaboration with the global design activities sub-process stewards.

At Boston Scientific, we value collaboration and synergy. This hybrid role can be located at any BSC Design site and requires being on-site at least three days per week.

Relocation assistance is not available for this position.

Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Your responsibilities will include:

• Develops integration strategies and approaches relating to Design Controls, Risk Management, and other areas of the Quality System as required.
• Delivers and manages completion of functional deliverables, including updates to documents, procedures, and knowledge sharing documents as required.
• Applies technical quality engineering principles and systematic problem-solving methodologies to acquisition products or sites.
• Investigates, identifies, and implements best-in-class Quality Engineering practices as requested by management.
• Demonstrated competency in design activities to support the development of products to meet or exceed internal and external requirements.
• Partnering with all upstream and downstream process owners to ensure the right linkages with the Global Risk management Process are maintained (i.e., production and process controls, material controls, post-market support) 
• Maintains and enhances cross-functional team relationships within divisions, manufacturing plants, distribution centers, and global BSC network.
• Advises management on potential improvements or enhancement to quality systems and processes in the company.
• Assists in identifying and developing tools that facilitate BEST4 processes

Required qualifications:

• Bachelor's degree in Science, Health, or Engineering
• Minimum of 5 years of related work experience in the medical device regulated industry.
• Working knowledge of US and International regulations and standards applicable to BSC including 21 CFR 806 & 820, ISO 13485, ISO 14971, EUMDR, CMDR, and MDSAP.
• High energy problem solver capable of driving items to closure.
• Strong presentation & communication skills.
• Computer skills required including Excel, Word, and PowerPoint.
• Potential global and US travel up to 40%.

Preferred qualifications:

• > 3 years of experience working on acquisitions.
• > 3 years working with Active Implantable devices.
• > 3 years working with Capital Equipment.
• Experience within BSC quality systems.
• Project Management Experience
• Experience working with functions such as Operations, Regulatory, Research and Development, Clinical, and Quality.

Requisition ID: 623735 

Minimum Salary: $ 89200 

Maximum Salary: $ 169500 

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

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 Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

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.

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