Design Assurance Engineer

$59,535 - $102,060/Yr

Koninklijke Philips N.V - Plymouth, MA

Full-time - Entry Level

Onsite - Plymouth, MA

Ambulatory Health Care Services

About the position

The Design Assurance Engineer will lead quality elements of Design Controls and product Design History File (DHF) for new product introductions and sustaining/design projects. This role focuses on driving quality norms associated with design engineering projects, supporting risk management processes, and ensuring compliance with regulatory standards throughout the product lifecycle.

Responsibilities

• Drive Quality norms associated with design engineering projects.
• Lead Quality Plan initiatives associated with Risk Management and Quality System integration.
• Support integration of Risk Management processes throughout the product lifecycle.
• Integrate post market surveillance processes into Design Controls and Sustaining initiatives.
• Analyze field performance, identify trends and risks, and take actions to mitigate adverse post market issues.
• Support the Regulatory Affairs department for submissions and respond to submission questions.
• Lead and support Corrective and Preventive Actions (CAPA) and QMS continuous improvement initiatives.
• Analyze situations/data using engineering principles to identify gaps between project work and QMS.
• Ensure quality responsibility for the transfer of new products and sustaining projects to manufacturing and operations quality teams.

Requirements

• 1+ years of experience in Quality Assurance, Design Engineering, Systems Engineering, or similar in a highly regulated industry.
• Experience with ISO 14971, 21 CR 820, ISO 13485, EU MDR, IEC 60601-1, IEC 62366, and IEC 62304 standards.
• Strong statistical background in verification, validation, hypothesis testing, sampling, multi-factor analyses, and measurement system analysis.
• Understanding of design quality tools, methods, and activities.
• Demonstrated expertise in managing complex projects and implementing cultural change.
• Proven track record of completing projects on-time that meet all objectives.
• Bachelor of Science in Engineering, Sciences, or a related field.

Nice-to-haves

• Excellent customer service and interpersonal communication skills.
• Experience leading presentations in front of peers and leadership.
• Hands-on problem solver that drives solutions within teams.
• Teamwork skills including influencing and building rapport with internal customers and stakeholders.

Benefits

• Generous PTO
• 401k (up to 7% match)
• HSA (with company contribution)
• Stock purchase plan
• Education reimbursement
• Annual incentive bonus