Principal Design Quality Engineer - New Product Development
$102,100–$194,000 year
Hybrid · Minnetonka, Minnesota, United States or Marlborough, Massachusetts, United States
Job Summary
Lead Design Assurance activities for active implantable technology within the New Product Development lifecycle. Serve as the quality representative on cross-functional development teams, driving compliance with Design Control, Risk Management, and regulatory expectations; author and maintain Design History File documentation; lead risk management activities (hazard analysis, FMEA, usability risk assessments) and support verification/validation, usability testing, and regulatory inspections. Collaborate with R&D, Manufacturing, Regulatory, and other functions to implement Design Controls based on Risk Management and customer needs. Work in a hybrid onsite/remote environment with roles based in Minnetonka, MN or Marlborough, MA. Relocation assistance is available; visa sponsorship is not offered. The role emphasizes strong knowledge of validation methodologies, statistical techniques, and quality engineering principles in the medical device domain.
Required Qualifications
- Bachelor’s degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, or related technical discipline
- Minimum of 7+ years of experience in Design Assurance, Quality Engineering, New Product Development, or related medical device/regulated industry experience
- Strong understanding of FDA Quality System Regulation (21 CFR Part 820), ISO 13485, ISO 14971, and Design Control requirements for medical devices
- Demonstrated experience applying Quality Engineering tools and methodologies
- Strong verbal and written communication skills with the ability to influence across functions and levels
- Demonstrated experience authoring and reviewing detailed technical documentation
- Self-motivated with strong problem-solving skills and a bias for action
- Ability to effectively collaborate in a hybrid onsite and remote work environment
Additional Requirements
- No H-1B sponsorship for this role
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