Staff Design Quality Engineer

Stryker • Waltham, MA

7d • Hybrid

About The Position

Stryker is hiring a Staff Design Quality Engineer to support new product development and quality activities throughout the medical device product lifecycle. The role partners with Research & Development, Regulatory Affairs, Manufacturing, Supplier Quality, and Operations to support design controls, risk management, product verification and validation, design transfer, and Quality Management System compliance in a regulated medical device environment.

This is a hybrid position based in Waltham, Massachusetts. Candidates must live within commuting distance and be able to work onsite several days per week. Travel is not required.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, Biomedical Engineering, Manufacturing Engineering, or a related technical discipline.
• At least 4 years of experience in Quality Engineering, Quality Assurance, or a related position within the medical device industry.
• Experience supporting new product development, including design control activities.
• Working knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, design controls, corrective and preventive action, change management, and process validation.
• Experience using electronic Quality Management Systems.
• Must reside within commuting distance of Waltham, Massachusetts and be able to work onsite several days per week.

Nice To Haves

• Certified Quality Engineer (CQE) certification or a comparable quality certification.
• Experience with Class II and/or Class III medical devices, including global requirements such as the European Union Medical Device Regulation and Medical Device Single Audit Program.
• Experience with statistical analysis, quality improvement methodologies, supplier quality management, auditing, software validation, or computerized system validation.

Responsibilities

• Represent Quality Engineering on cross-functional new product development teams and provide quality and regulatory guidance throughout the product lifecycle.
• Review and approve design control documentation, including design plans, user needs, design inputs and outputs, verification and validation protocols and reports, design reviews, and Design History File documentation.
• Apply risk management principles in accordance with ISO 14971 and participate in design reviews and product risk assessments.
• Support verification, validation, process validation, and design transfer activities to ensure requirements and acceptance criteria are addressed.
• Evaluate product requirements, specifications, engineering changes, and manufacturing changes for quality and regulatory impact.
• Investigate product and development issues using root cause analysis and support corrective and preventive actions, nonconformances, change control, and complaint investigations.
• Maintain quality documentation and records in accordance with ISO 13485, FDA 21 CFR Part 820, and applicable global medical device requirements.
• Support internal and regulatory audits, supplier quality activities, regulatory submissions, and updates to quality procedures, work instructions, and quality system requirements.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior