Senior Design Quality Engineer

Boston Scientific•Maple Grove, MN

2d•Hybrid

About The Position

The position will require you to utilize extensive quality knowledge and technical skills to help support and execute integration activities, for a compliant and efficient integration of BSC design controls, and related QMS deliverables. You will work in a highly collaborative environment, with a team of quality engineers focused on product sustaining support of the integration. This position will be located at the Maple Grove, MN site. At Boston Scientific, we value collaboration and synergy. This role follows hybrid work model, requiring employees to be in our local office at least three days per week.

Requirements

Minimum of a bachelor’s degree in mechanical, electrical, or biomedical engineering (or other related technical discipline)
Minimum 4+ years experience in design assurance, new product development or sustaining in medical device / regulated industry experience
Self-motivated with a passion for solving problems and a bias for action
Strong communication skills (verbal & written)
Demonstrated use of Quality tools/methodologies
Ability to effectively work and collaborate in a mixed onsite + remote environment
Demonstrated experience creating detailed technical documents

Nice To Haves

Quality Integration experience
ISO 13485, ISO 14971 and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis
Hands-on technical/mechanical experience and aptitude
Ability to influence and work with a team collaboratively
Demonstrated leadership of problem solving
Experience with design changes, non-conforming events and corrective action

Responsibilities

Lead Design Assurance activities throughout the product lifecycle, ensuring compliance with Design Control requirements, quality system procedures, and applicable regulatory standards.
Partner with cross-functional teams, including R&D, Manufacturing, Regulatory Affairs, Operations, and Marketing, to ensure quality objectives are integrated into product development and sustaining engineering activities.
Establish, implement, and maintain Design Controls based on Risk Management, customer needs, intended use, and manufacturing considerations.
Develop, review, and maintain Design History File (DHF) documentation, including Design Inputs, Design Outputs, specifications, drawings, traceability matrices, and design review documentation.
Lead and maintain product Risk Management activities, including Risk Management Plans, Hazard Analyses, Design FMEAs, Fault Tree Analyses, Task Analyses, and Risk Management Reports in accordance with ISO 14971 and applicable company procedures.
Provide Design Quality oversight for verification, validation, and usability engineering activities to ensure compliance with internal procedures and applicable regulatory requirements, including IEC/ISO 62366 where applicable.
Evaluate design changes throughout the product lifecycle, ensuring proposed changes are appropriately analyzed, risk assessed, documented, verified, validated, approved, and implemented in accordance with Design Control requirements.
Support sustaining engineering activities by evaluating product, process, packaging, and manufacturing changes to ensure continued compliance with quality and regulatory requirements.
Assess post-market information, including complaints, nonconformances, and product performance data, to evaluate product risk, identify trends, and support risk-based decision making.
Apply structured problem-solving methodologies (e.g., 5 Whys, DMAIC, Fishbone, Is-Is Not) to investigate quality issues, identify root cause, implement effective corrective actions, and drive continuous improvement.
Develop technical documentation supporting Design Assurance activities, including protocols, reports, technical justifications, risk assessments, engineering evaluations, and quality plans.
Ensure product development activities comply with applicable regulations and standards, including FDA Quality System Regulation (21 CFR Part 820/QMSR), ISO 13485, ISO 14971, and other applicable global regulatory requirements.
Provide quality guidance during design reviews, risk reviews, and cross-functional project meetings, serving as the Design Quality representative on product development teams.
Lead or support quality planning activities, including development of Quality Plans, project quality deliverables, and project tracking to ensure milestones and regulatory commitments are achieved.
Evaluate the effectiveness of quality systems, processes, and product development practices, identifying opportunities to improve compliance, efficiency, and product quality.
Collaborate with project managers and functional leaders to establish priorities, manage deliverables, and ensure timely execution of Design Quality activities.
Partner with cross-functional teams to identify and implement value improvement and continuous improvement initiatives that enhance product quality, compliance, manufacturability, and business performance.
Support internal, customer, and regulatory audits by preparing documentation, presenting objective evidence, responding to audit observations, and implementing corrective actions as required.
Proactively identify quality, compliance, and project risks, communicate findings to stakeholders, and drive timely resolution through appropriate risk mitigation strategies.
Provide technical leadership, mentoring, and guidance to junior engineers and cross-functional teams on Design Control, Risk Management, Quality System requirements, and best practices.
Stay current with evolving regulatory requirements, industry standards, and Design Assurance best practices, incorporating improvements into quality systems and product development processes.

Benefits

Relocation assistance is not available for this position at this time.
Boston Scientific will not offer sponsorship or take over sponsorship of an employment VISA for this position at this time.
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).
It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.
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.