Manager, Mechanical Engineering
Fluxergy
Full-time
On-site
Irvine, California, United States
$155,000 - $170,000 USD yearly
About Us
Fluxergy is a rapidly growing in vitro diagnostics company innovating on the cutting-edge of laboratory testing. We’re 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 company’s 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.
About the Role
As the Manager, Mechanical Engineer– Platform Engineering at Fluxergy, you will be leading a team that is responsible for the mechanical design and development of our cutting-edge diagnostic platforms, with a strong focus on innovation, technical excellence, and new product development. You’ll work with a small but high-performing team of engineers and drive R&D initiatives from concept through commercialization.
This role combines technical leadership with hands-on 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 diagnostic hardware and advancing Fluxergy’s product roadmap in alignment with the company’s long-term 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 forall 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 cross-functional 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 stack-ups, 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.
- Provide guidance and technical expertise toengineers, fostering a collaborative, technically curious, and accountable team culture.
- Manage all HR duties that come with managing a team; regular 1:1s, mentoring, mid-year and annual reviews, manage time off requests, counseling, etc...
What You'll Need to Have
- B.S. or M.S. in Mechanical Engineering or closely related field.
- 8+ years of experience in mechanical product development, preferably within the medical device or diagnostics industry.
- 5+ years of mechanical engineering leadership experience with multiple direct reports.
- Experience managing small engineering teams through the product development lifecycle.
- Experience working on multiple simultaneous projects from concept through release and sustaining engineering.
- Expert-level proficiency in SolidWorks and CAD-based 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. Equivalent safety critical experience such as aviation, transport, etc. may be considered.
- 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 cross-functionally in fast-paced, iterative environments.
- Excellent problem-solving abilities and attention to detail.
Interview Process
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 isn’t 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
- 2-week 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: $155,000 - $170,000/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.
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