Mechanical Engineer - Sustaining Engineering

Job Description

Job Description

Bring your mechanical engineering expertise to Sentec’s growing Sustaining Engineering team and help shape the future of respiratory care. In this impactful role, you will support design changes, troubleshoot field and production challenges, and help ensure our products continue to meet the high quality and regulatory standards expected in the medical device industry.

This is an exciting opportunity to partner with cross-functional teams, solve meaningful engineering challenges, and help improve the manufacturability and performance of Sentec’s respiratory devices. You will investigate and analyze complex issues, develop practical and innovative solutions, and take ownership of engineering assignments that support the continued success, reliability, and growth of our products.

Essential Duties and Responsibilities:

• Lead and support design changes and engineering updates for existing medical devices
• Collaborate with cross-functional teams to support product and manufacturing improvements
• Create and manage design documentation including 3D CAD models, drawings, specifications, and BOMs.
• Conduct engineering analyses, including tolerance stack-ups, material selection, and DFM/DFA.
• Perform root cause investigation, failure analysis, and testing for post-market surveillance and CAPA activities .
• Define or revise user needs, design inputs, and product requirements as needed for design or regulatory compliance updates.
• Support verification and validation testing to ensure the product meets design requirements, and assist with risk management activities such as FMEA and hazard analysis.
• Ensure all designs comply with applicable standards and regulations (e.g., ISO 13485, FDA 21 CFR Part 820, ISO/IEC 60601).

Requirements

Qualifications/ Education:

• Bachelor’s degree in mechanical engineering preferred or equivalent work experience required.
• 3+ years’ experience working as a Mechanical Engineer; medical device industry experience preferred
• Proficiency with 3D CAD tools (e.g., SolidWorks, Creo)
• Strong understanding of mechanical fundamentals: GD&T, tolerance analysis, DFM/DFA, and materials
• Familiarity with ISO 13485 and FDA design controls preferred
• Ability to develop a working knowledge of standards and regulations required.

Benefits

• Meaningful work in a rapidly growing company with opportunity for advancement
• Directly influence the quality of products and make a difference for patients worldwide
• Opportunities for professional and personal growth

Sentec offers competitive benefits like Medical, Dental, Vision, HSA, FSA, and 401K matching, as well as paid parental leave , a wellness stipend and tuition reimbursement. Sentec emphasizes employee voices and recognizes hard work making it a promising environment for professional growth. Sentec focuses on delivering impactful healthcare products and improving patient care.

By choosing a career at Sentec, you’re not just choosing a job – you’re embracing the chance to make a real impact, contributing to the development of innovative medical solutions that support the wellbeing of individuals worldwide.

Sentec is a Swiss-American medical device company specializing in respiratory care. Since its founding in 1999, Sentec utilizes a deep-tech approach that is founded on advanced science and avant-garde technologies for respiratory patients across care areas. Sentec provides healthcare professionals worldwide with non-invasive, continuous monitoring and effective therapeutic solutions.