Senior Mechanical Engineer
Irvine, CA - USA
Job Summary
Fluxergy is a rapidly growing in vitro diagnostics company innovating on the cutting-edge of laboratory testing. Were developing the first and only multi-modal point-of-care platform that enables molecular clinical chemistry immunoassay and hematology testing on the same system.
Our platform spans many markets including the clinical veterinary and food safety industries. We are seeking self-motivated problem solvers who are excited to help decentralize traditional laboratory infrastructure.
At the core of our companys identity is a strong foundation in engineering. We take great pride in our commitment to critical thinking and pragmatic problem-solving through a modular and systemic perspective. We hold the conviction that transparent communication coupled with the flexibility to adjust to evolving scenarios and the willingness to venture beyond familiar territories is crucial to both our success and yours.
Our product: the Role
- Design and develop mechanical subsystems assemblies and components using SolidWorks from concept through design transfer and production.
- Collaborate with electrical software and manufacturing teams to integrate mechanical electronic and optical systems into reliable products.
- Design and validate fixtures tooling and test equipment to support development manufacturing and quality objectives.
- Perform engineering analyses including FEA tolerance stack-ups and reliability assessments to optimize performance and mitigate risk.
- Lead design reviews DFM/DFA activities verification testing and troubleshooting efforts to improve product quality and manufacturability.
- Author and maintain engineering documentation subsystem requirements and design history records in compliance with regulated development processes.
- Partner with suppliers and manufacturing teams to support component qualification new product introductions and design transfer activities.
- Mentor junior engineers and contribute to continuous improvement of engineering processes tools and best practices.
- B.S. or M.S. in Mechanical Engineering or a related discipline.
- 5 years of experience developing electromechanical products preferably in medical devices or other regulated industries.
- Strong proficiency in SolidWorks including 3D modeling mechanical drawings and GD&T.
- Experience with electro-mechanical integration PCBA collaboration fixture/tooling design and prototyping.
- Knowledge of injection molding DFM/DFA principles and manufacturing processes.
- Experience performing FEA tolerance analysis and reliability testing.
- Familiarity with ISO 13485 FDA Quality System Regulations IEC 60601 or similar regulated product development standards.
- Strong communication problem-solving and collaboration skills with the ability to manage multiple priorities and adapt in a dynamic environment.
- Demonstrated accountability initiative and a passion for mentoring and developing others.
- Medical device diagnostic instrument or life sciences industry experience.
- Experience with optical systems filters imaging components or sensor integration.
- SolidWorks Professional Certification GD&T Certification or Six Sigma certification.
Our interview processes my differ slightly from role-to-role; however most of our interviews will follow a similar pattern:
- Recruiter Interview
- Hiring Manager interview
- On-site Interview
- Decision
We are an early-stage company and may change our interview process from time-to-time but our hope is everyone who interviews with us has a positive experience even if an offer isnt presented.
- 95% medical benefit premiums paid by Fluxergy and covers employee partner and dependents
- 100% dental and vision premiums paid for employee partner and dependents
- 100% Life Insurance premiums paid for the employee
- 15 paid vacation days
- 2-week paid winter break
- 7 company paid holidays
- 5 paid sick days
- Wear lots of hats / accelerate your career growth!
- We are a flat organization by design lots of visibility!
- Many of our current leaders started their career with Fluxergy!
Fluxergy is an Equal Opportunity Employer and is committed to building an inclusive workplace. Qualified applicants will receive consideration for employment without regard to any protected characteristic under applicable federal state or local law.
If you require a reasonable accommodation during the application or interview process please let us know at any point during the hiring process.
Fluxergy participates in EVerify. Employment eligibility will be verified after hire in accordance with federal law.
Fluxergy is committed to protecting your personal data. Please review our Privacy Policy.
About Company
Fluxergy is the first open platform for multimodal, point-of-care assay development and testing.