Mechanical Engineer - Sustaining Engineering

Sentec•Sandpoint, ID

About The Position

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.

Requirements

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.

Nice To Haves

medical device industry experience preferred
Familiarity with ISO 13485 and FDA design controls preferred

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).