USA - Sr. Principal Engineer

Description

Join a high-impact team driving innovation in medical device development-where your expertise in software and hardware quality engineering will directly shape the future of healthcare technology.

Schedule & Location:

• Hours: 8:00 AM - 5:00 PM (Pacific Time)
• Work Setup: Hybrid preferred (3 days/week onsite or as needed)
• Local candidates preferred
• Open to remote with occasional travel to site

Employment Type:

• Contract with possibility of extension
• Temp-to-hire potential

Job Description

Provide Quality Engineering leadership for software and hardware product development teams, ensuring compliance with regulatory standards and driving quality throughout the product lifecycle.

Essential Duties & Responsibilities

Primary Responsibilities:

• Lead design control, risk management, and other quality engineering activities for new product development.
• Develop and maintain Risk Management Files (RMF): risk plans, hazard analysis, dFMEAs, pFMEAs, and reports.
• Review and approve Design History File (DHF) documentation.
• Oversee product development plans, design inputs/outputs, verification/validation, and test protocols/reports.
• Guide statistical methods and analyses for design verification and validation.
• Act as SME for software quality: code reviews, software security analysis, software BOM, and best practices.
• Participate in design reviews for hardware/software lifecycle management.
• Support production transfer and post-deployment phases.
• Address anomalies (e.g., bugs, cybersecurity issues) and guide remediation.

Secondary/Backup Responsibilities:

• Lead updates to the Quality System based on new regulations and standards.
• Own CAPA resolution related to design control.
• Support released products and interface with customer support.
• Assist other Quality System areas as needed.

Requirements

Qualifications

Required:

• 8+ years of progressive Quality Engineering experience in the medical device industry.
• Hands-on support for hardware and software development.
• Strong knowledge of:
• FDA CFR 820
• ISO 13485, ISO 14971
• IEC 60601 series, IEC 62304, IEC 62366
• Experience with:
• Design, development, verification, validation, and testing of medical devices
• Statistical tools and data analysis
• Excellent communication and presentation skills
• Ability to manage multiple projects and advocate for quality
• Proficient in Microsoft Office, Adobe Acrobat, Minitab, and other business software

Preferred:

• ASQ CQE certification and/or Six Sigma Black Belt/Green Belt
• Experience with:
• Artificial Intelligence (AI) and AAMI TIR45 framework
• Software as a Medical Device (SaMD)
• Cloud infrastructure

Education:

• B.S./M.S. in Engineering (Biomedical, Software, Electrical, etc.) or equivalent scientific degree

Technology Doesn't Change the World, People Do.

Robert Half is the world's first and largest specialized talent solutions firm that connects highly qualified job seekers to opportunities at great companies. We offer contract, temporary and permanent placement solutions for finance and accounting, technology, marketing and creative, legal, and administrative and customer support roles.

Robert Half works to put you in the best position to succeed. We provide access to top jobs, competitive compensation and benefits, and free online training. Stay on top of every opportunity - whenever you choose - even on the go. Download the Robert Half app and get 1-tap apply, notifications of AI-matched jobs, and much more.

All applicants applying for U.S. job openings must be legally authorized to work in the United States. Benefits are available to contract/temporary professionals, including medical, vision, dental, and life and disability insurance. Hired contract/temporary professionals are also eligible to enroll in our company 401(k) plan. Visit roberthalf.gobenefits.net for more information.

2025 Robert Half. An Equal Opportunity Employer. M/F/Disability/Veterans. By clicking "Apply Now," you're agreeing to Robert Half's Terms of Use.