Senior Design Quality Engineer

Boston Scientific; Maple Grove (MN); Hybrid; USD 85,000 - 162,000; Full time

Job summary

Boston Scientific is seeking a Design Quality Engineer at its Maple Grove, MN site. The role focuses on Design Assurance activities to ensure compliance with Design Controls and regulatory standards across the product lifecycle.

You will partner with R&D, Manufacturing, Regulatory, and Operations to embed quality into development and sustaining efforts. The position requires a bachelor’s degree in engineering and 4+ years in a regulated medical device environment, with strong problem-solving and

Qualifications

• Bachelor's degree in engineering or related technical discipline.
• 4+ years in design assurance, new product development or sustaining in medical device industry.
• Self-motivated with problem-solving and action bias.
• Demonstrated use of quality tools/methodologies.
• Ability to work effectively in mixed onsite + remote environment.
• Experience creating detailed technical documents.

Responsibilities

• Lead Design Assurance activities across the product lifecycle, ensuring compliance with design control requirements and regulatory standards.
• Collaborate with R&D, Manufacturing, Regulatory, Operations and Marketing to embed quality objectives in development and sustaining activities.
• Establish, implement and maintain Design Controls based on risk management and user needs.
• Develop and maintain Design History File documentation and traceability.
• Lead Risk Management activities including FMEAs and hazard analyses per ISO 14971.
• Provide Design Quality oversight for verification, validation and usability engineering.

Skills

Quality tools/methodologies

Design Controls

Risk Management

Cross-functional collaboration

Documentation

Education

Bachelor's degree in mechanical, electrical, or biomedical engineering

ISO 13485 understanding

Tools

FDA QSR 21 CFR Part 820

Job description

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 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.

Work Mode
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.

Relocation
Relocation assistance is not available for this position at this time.

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

Your responsibilities will include:

• 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.

Required qualifications:

• 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
• Demonstrated use of Quality tools/methodologies
• Ability to effectively work and collaborate in a mixed onsite + remote environment
• Demonstrated experience creating detailed technical documents

Preferred qualifications:

• 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

Requisition ID:636108

Minimum Salary:$85000

Maximum Salary: $161500

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.

Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life byprovidinga broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological,neurologicaland urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn .

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 specificprohibited substancetest 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.

Nearest Major Market: Minneapolis
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