What are the responsibilities and job description for the Mechanical Engineer (Medical Device) position at BRIDGEMED SOLUTIONS INC?
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
BridgeMed Solutions, Inc is seeking a Mechanical Engineer. Training will be provided.
Are you passionate about pioneering medical innovations? Join our dynamic team at BridgeMed 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: Mechanical Engineer
Experience: 5 years of experience in research and development, experience in medical device is a plus.
Location: Local candidates only (must live in Orange County)
Job Type: Full Time, 100% In-House
Salary: $25-$40 DOE (Non-Exempt, Exempt)
Benefits: PTO, Sick days, Holiday Pay, 401k, Health-Vision-Dental Coverage, Free Lunch Fridays, Professional Development Opportunities
Principal Duties and Responsibilities
- 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
Skills and Qualifications
- Bachelor's or Master's degree in Engineering (Biomedical, Mechanical, or related field).
- Minimum of 5 years of experience in R&D, 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.
Salary : $25 - $40