Associate Director, Hardware

Company: FluxErgy LLC.
Location: Irvine
Posted on: March 18, 2023

Job Description:

About UsFluxergy is a rapidly growing biomedical company on the cutting edge of laboratory testing. We're developing a true multi-modal point of care device, the kind of which has never been conceived, and we'd love to have you as part of the team!Our technologies span many markets including healthcare, veterinary, food safety, and wellness industries. We are seeking self-motivated problem solvers who are excited to help decentralize traditional laboratory infrastructure.Our roots are squarely rooted in engineering. We pride ourself on critical thinking and solving problems pragmatically, from a modular and systems-level approach. We believe that open and clear communication along with the ability to adapt to changing situations and working outside of your comfort zone is paramount to our success and yours.Our product: About the RoleAre you passionate about making an impact in the lives of others? Does the idea of decentralizing laboratory infrastructure at a global scale appeal to you? Interested in working with talented, kind, and capable like-minded people - all on a mission to succeed?If you answered yes to the three questions above, please read on. We'd love to hear from you!Reporting to our Sr. Director of Compliance and Development, you'll be directly involved in our day-to-day engineering activities, as well as deeply involved in the shaping of our long-term infrastructure and strategy.You'll be directly responsible for taking the newest version of our product all the way from design, FDA approval, then eventually to market. You'll hire, lead, manage, and mentor a team of passionate 'll also work closely with our Quality teams to continually improve our product development structure.What You Will Do

• Take the newest version of our product from design input to production release.
• Hire, manage, and mentor a team of Mechanical and Electrical Engineers.
• Oversee FDA approval process; help remove blockers.
• Work closely with our Quality team to continually improve product development process.
• Drive key projects and initiatives by collaborating with cross functional departments and executive-level stakeholders.What You'll Need to Have
  • Experience taking a medical device product from concept through to production and a successful 510(k) submission.
  • Experience hiring, mentoring, and growing a team of engineers.
  • Enough hands-on engineering experience to effectively mentor your team; examples: you've designed and developed a range of components via machining, sheet metal and injection molding for complex electromechanical assemblies.
  • Experience managing vendors and serving as the main technical point of contact.
  • Experience implementing GD&T to minimize build time and scrap for production assemblies.
  • Experience working closely with quality teams to create continuous product improvements.Interview ProcessOur 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.BenefitsExcellent 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 daysA 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: $140-000 - $195,000Additional InformationFluxergy 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 participates in the E-Verify program. Please click,, for more information.

Keywords: FluxErgy LLC., Irvine , Associate Director, Hardware, Executive , Irvine, California