Engineer; Mechanical - Medical Device
Listed on 2026-01-23
-
Engineering
Quality Engineering, Biomedical Engineer, Manufacturing Engineer, Medical Device Industry
Benefits
- 401(k)
- 401(k) matching
- Company parties
- Competitive salary
- Dental insurance
- Free food & snacks
- Health insurance
- Opportunity for advancement
- Paid time off
- Vision insurance
Bridge Med Solutions, Inc is seeking a Manufacturing Engineer. Training will be provided.
Are you passionate about pioneering medical innovations? Join our dynamic team at Bridge Med Solutions, where we're revolutionizing healthcare through cutting‑edge technology. We are an Irvine-based Contract Manufacturing Organization that is ISO and FDA certified. We are a privately owned company that specializes in tissue heart valve technology. We additionally custom produce transcatheter valves for various clients. Embrace the opportunity to make a meaningful impact on patient care while collaborating with talented professionals in a fast‑paced startup environment.
Apply now and be part of our journey towards transforming lives.
Job Title: Manufacturing Engineer
Experience: +3 years of experience in Engineering, experience in medical device is a plus.
Location: Local candidates only (must live in Orange County)
Job Type: Full Time, 100% In-House
Salary: $33-$43 DOE (Non‑Exempt)
Benefits: PTO, Sick days, Holiday Pay, 401k, Health-Vision-Dental Coverage
Principal Duties And Responsibilities- Experience in medical device manufacturing.
- Suture Experience is a PLUS! - Lead and manage engineering projects from concept through to prototype and market release, ensuring alignment with regulatory requirements (FDA, ISO).
- Collaborate with cross‑functional teams, including engineering, quality assurance, and operations, to develop project plans, schedules, and risk assessments.
- Develop and review technical documentation, including design specifications, test protocols, and validation reports, to support product development and regulatory submissions.
- Oversee the execution of validation activities for new and legacy medical devices, ensuring they meet intended performance and safety standards.
- Facilitate root cause investigations for non‑conformance issues, implementing corrective actions and driving continuous improvement initiatives.
- Project and client management is a must.
- Bachelor's or Master's degree in Engineering (Biomedical, Mechanical, or related field).
- Minimum of 3 years of experience in Engineering, medical device industry preferred with a strong understanding of FDA regulations and ISO standards.
- Proven experience in project management and cross‑functional team collaboration.
- Strong analytical skills with the ability to conduct detailed assessments and develop effective solutions.
- Excellent communication skills, both written and verbal, with the ability to present complex information clearly to stakeholders.
- Proficient in Microsoft Office and engineering design software; familiarity with statistical analysis tools (e.g., Minitab) is a plus.
- Detail‑oriented with strong organizational skills, capable of managing multiple projects in a fast‑paced environment.
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