The Role:

Our client is a global leader in the medical device industry, specializing in the cardiac care space. They are seeking a Sustaining Engineer to collaborate cross-functionally with Quality Assurance, Regulatory Affairs and Manufacturing teams. This role involves working across the entire product portfolio to streamline processes and help bring life-saving products to market more efficiently.

Responsibilities:

• Ensure product requirements are current and applied to all products.
• Conduct gap assessments and recommend improvements.
• Launch and manage design and process improvement projects.
• Contribute to CAPA processes for product compliance.
• Draft protocols, reports, and perform product testing for Design V&V.
• Build strong partnerships with cross-functional leaders.
• Incorporate customer needs into design requirements.
• Ensure compliance with GMP, GDP, ISO, EU MDR, and company policies.
• Document and share knowledge to enhance company processes.

Qualifications:

• Bachelor’s Degree in Engineering or a related technical field.
• 3+ years of relevant experience with product lifecycle support.
• Strong problem-solving skills and ability to meet objectives.
• Knowledge of design controls and V&V testing.
• Ability to balance schedule, cost, and quality.
• Experience with new product development or change management in medical devices or IVD.
• Familiarity with statistical techniques and applications.
• Strong communication, teamwork, and influencing skills.
• Proven ability to deliver outcomes in ambiguous environments.
• Knowledge of EUMDR, ISO13485, ISO14971, FDA GMP/QSR, GDP, CFR 820.
• Onsite availability at Burlington, MA office.
• Willingness to travel up to 10% domestically and internationally (per company policies).