Lead Mechanical Engineer
Lead Mechanical Engineer
Posted on :
20-05-2025
Employer Active
1 Vacancy
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Job Description
About Us
Fluxergy is a rapidly growing in vitro diagnostics company innovating on the cuttingedge of laboratory testing. Were developing the first and only multimodal pointofcare 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 selfmotivated 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 problemsolving 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
As the Lead Mechanical Engineer Platform Engineering at Fluxergy you will be part of a team responsible for the mechanical design and development of our cuttingedge diagnostic platforms with a strong focus on innovation technical excellence and new product development. Youll work with a small but highperforming team of engineers and drive R&D initiatives from concept through commercialization.
This role combines technical leadership with handson engineering and requires a deep understanding of mechanical systems product development processes and design for manufacturability. You will play a key role in building scalable robust medical hardware and advancing Fluxergys product roadmap in alignment with the companys longterm vision.
Team culture:
Positive
Proactive
Accountable
Team oriented
Continuous learner
Great communicator
Build strong working relationships
Contribute to a productive team culture
What You Will Do
- Design and develop medical device hardware from concept to market.
- Be responsible for all aspects of mechanical design prototyping testing and design transfer activities.
- Drive innovation by identifying and recommending new technologies materials and design methodologies that improve product performance reliability and cost.
- Own product development documentation for assigned projects including design history files BOMs engineering drawings and verification/validation reports in compliance with ISO 13485 regulatory standards FDA guidance.
- Support crossfunctional R&D efforts by collaborating with electrical software automation and manufacturing teams to ensure seamless hardware integration.
- Create and review engineering analyses such as FEA tolerance stackups reliability testing and analysis failure mode analysis and risk assessments.
- Comply with and assist in improving mechanical design standards workflows and best practices across the team.
- Work with external vendors manufacturers and material suppliers.
- Mentor junior engineers fostering a collaborative technically curious and accountable team culture.
What Youll Need to Have
- B.S. or M.S. in Mechanical Engineering or closely related field.
- 7 years of experience in mechanical product development preferably within the medical device or diagnostics industry.
- 2 years of leading a team of engineers through all phases of product development lifecycle.
- 2 years of mechanical engineering leadership experience.
- Experience working on multiple simultaneous projects from concept through release and sustaining engineering.
- Expertlevel proficiency in SolidWorks and CADbased mechanical design.
- Deep understanding of DFM DFA DFAM FEA GD&T and mechanical design principles.
- Experience with a range of manufacturing processes including CNC machining injection molding blow molding sheet metal fabrication and additive manufacturing.
- Familiarity with integrating optomechanical fluidics and electronic components into system designs.
- Proficiency with machine shop tools for prototyping and testing.
- Proficiency with the Atlassian ecosystem is a strong plus (Jira Confluence etc.)
- Optical design experience a plus.
- Strong experience working in regulated environments; knowledge of ISO 13485 ISO 9001 IEC 60601 and FDA QSRs and guidance documents strongly preferred.
- Ability to generate and manage design documentation aligned with FDA and Fluxergy QMS requirements.
- Clear written and oral communication skills and proven ability to collaborate crossfunctionally in fastpaced iterative environments.
- Excellent problemsolving abilities and attention to detail.
Interview Process
Our interview processes my differ slightly from roletorole; however most of our interviews will follow a similar pattern:
Recruiter Interview
Hiring Manager interview
Onsite Interview
Decision
We are an earlystage company and may change our interview process from timetotime but our hope is everyone who interviews with us has a positive experience even if an offer isnt presented.
Benefits
Excellent Medical/Dental Benefits
99% 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
Work Life Balance Minded Time Off
15 paid vacation days
2week paid winter break
7 company paid holidays
5 paid sick days
A Work Culture Which Believes in Promoting from Within
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!
Salary Range: $135000 $145000/yr
Additional Information
Fluxergy is an equal opportunity employer. We do not discriminate on the basis of race color religion sex sexual orientation gender identity marital status age disability national or ethnic origin military service status citizenship or other protected characteristic.
Fluxergy is committed to protecting your personal data. Please review our Privacy Policy.
Employment Type
Full-Time
Key Skills
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