Medical Device Engineer (60131)

Job Summary
We are seeking a Medical Device Engineer to play a critical role in supporting our existing portfolio and helping advance our product development capabilities. This role is designed for an engineer who thrives in a compliance-driven environment while also bringing curiosity and initiative to explore future opportunities.

The position involves cross-functional teamwork, supplier collaboration, and oversight of documentation and testing activities. While the primary focus is sustaining engineering, you will also have opportunities to engage in early-stage concept development and innovation planning.

What Makes This Role Unique

• Be the technical anchor for existing products, ensuring they remain safe, effective, and compliant.

• Contribute to future product directions, supporting concept development and identifying unmet needs.

• Work closely with external consultants and global suppliers, managing deliverables and aligning with internal standards.

• Help strengthen internal capabilities by supporting design control education and process improvements.

Key Responsibilities

• Support existing products in the market through sustaining engineering activities

• Contribute to identifying new product opportunities and participate in early-stage concept discussions

• Collaborate with suppliers to ensure design and quality alignment

• Manage and coordinate work with external consultants and contractors

• Support implementation and education of design control processes across teams

• Lead remediation of risk management files in alignment with ISO 14971 and FDA QSR

• Create and maintain product specifications and technical documentation

• Review and manage engineering change requests (ECRs/ECOs)

• Develop, execute, and review testing protocols and validation plans

• Apply statistical methods and sampling plans to support testing and risk analysis

Preferred Qualifications

• 3+ years of experience in medical device engineering

• Strong background in sustaining engineering and risk management remediation

• Experience with statistical analysis, sampling plans, and test method validation

• Skilled in writing and reviewing testing protocols and execution plans

• Familiarity with ISO 13485, ISO 14971, and FDA 21 CFR Part 820

• Proven experience managing contractors and working with suppliers

• Excellent communication, leadership, and team collaboration skills

• Experience in product development and concept creation is a plus

• Experience with human factors, usability, and ergonomics is a plus

• Interest in contributing to future innovation and new product initiatives