Sr. Design Quality Engineer- Service (Contract)

About the role

This position is responsible for ensuring product quality throughout the design lifecycle while serving as a key liaison between Engineering and the Service organization. This role drives design robustness, field performance improvement, and customer satisfaction by proactively incorporating serviceability, reliability, and field feedback into product development and continuous improvement initiatives.

Responsibilities

• Act as the primary quality liaison to the Service organization.
• Support Design for Reliability (DFR), Design for Manufacturability (DFM), and Design for Serviceability (DFS) initiatives.
• Review hardware and system-related verification and validation strategies for the Service organization and ensure timely execution.
• Co-develop the project process validation strategy and review IQ/OQ/PQ/TMV protocols for service tools, equipment, software, and field processes.
• Participate in development activities, including design reviews, requirements analysis and tracing, and configuration management.
• Serves as a technical resource for risk management activities for hardware and systems in compliance with ISO 14971 and IEC 60601.
• Review test plans, and test cases based upon the product and component level requirements, ensuring that appropriate statistical techniques are applied.
• Review and approve V&V system maintenance such as reworks and modifications and track.
• Partner with cross-functional teams to collaborate on root cause analysis of identified design issues and identify appropriate corrective and preventive action. Use the NC and CAPA systems as needed to structure activities.
• Support field service engineering requests and assess serviceability risks.
• Partner with PMO to apply project management tools to define project deliverables and establish a project schedule.
• Foster a culture of quality throughout the organization by sharing best practices and promoting quality awareness.

Requirements

• BS in Engineering or Technology, Mechanical, Industrial, Electrical, Life Sciences, etc.
• Minimum of 4 years of Engineering work experience with a BS in the medical device or similarly regulated industry or minimum of 2 years of Engineering work experience with a PhD.
• Preferred 2 years experience in a development QE function in a regulated environment
• Experience in meeting Design Control and DHF requirements with R&D teams.
• Experience with Quality Management System to meet US FDA and ISO/MDR requirements.
• Experience with Risk Management, FMEA, Hazard Analysis, GD & T requirements.
• Experienced with statistical skills to define/train on test sample size and data analysis techniques.
• Experienced in Microsoft Office, Google Suite, Jama, and ePLM/eQMS systems.

Qualifications

• Must be a self-starter, team builder, and excellent in verbal and written communication.
• PREFERRED: Experience working in a clinical setting, and or field service
• PREFERRED: Certifications: CQE, CQA(BM), CQM, 6 Sigma, etc

Skills

• Strong problem-solving and analytical skills.
• Excellent communication and interpersonal skills.
• Ability to work independently and as part of a team.
• Knowledge of medical device regulations and quality systems.
• Experience with statistical methods and data analysis.
• Proficiency in Microsoft Office and related software.

Benefits

Actual pay will be adjusted based on an individual's skills, experience, education, and other job-related factors such as location as permitted by law. Total compensation may also include additional forms of incentives.

California Pay Range: $70 - $90 USD

Benefits & Perks (For Full Time Employees):

• Competitive Salary
• Comprehensive health insurance including Medical, Dental and Vision + HSA and FSA options
• Equity & Bonus Program
• Life Insurance (company paid & supplemental) and Disability insurance
• Mental health support through medical insurance programs
• Legal and Pet Insurance
• 12+ paid holidays, Flexible Time Off + Sick Time
• Paid parental leave
• In-office snacks and beverages
• In-office lunch stipend
• Learning & Development Opportunities: On-demand online training and book reimbursement
• Team building and company organized social and celebration events

Noah Medical may offer remote, hybrid, or onsite work arrangements within the state of California depending on the specific team and/or role where applicable.

Noah Medical is an Equal Opportunity Employer. We celebrate diversity and are committed to ensuring an inclusive environment for our employees. Applicants are considered for all positions without regard to race, color, religion, sex or gender, gender identity or expression, sexual orientation, national origin, ancestry, age, genetic information, physical or mental disability, marital or protected military or veteran status, or any other consideration made unlawful by federal, state or local laws.