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Hardware Compliance & Manufacturing Engineer

Hardware Compliance & Manufacturing Engineer

PanthrSan Diego, United States
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Team Panthr

Expect the unexpected!

We are the first zero-BS talent matchmaker. Empowering individuals through their job seeking journey whilst finding the perfect candidate that fits not only a role but a company vision.

From start to finish, we focus on making the recruitment process smooth and positive for everyone involved.

With more than 15 years of experience in the field, we make use of real data insights, professional expertise and technology. Although we offer worldwide service, our feet are always on the ground and trust is at the heart of what we do, built on transparency and a genuine commitment to seeing you succeed.

Meet our client

A wellness-focused technology star-up

About the role

We’re seeking a Compliance & Manufacturing Specialist to own product compliance documentation, coordinate testing and certifications, and oversee manufacturing processes. You’ll work closely with internal teams and contract manufacturers to ensure our health-focused hardware meets global standards (CE, FCC, RoHS, ISO 13485) and is built for quality and scale. This is a cross-functional role for someone experienced in compliance, quality, and production within consumer electronics or medical devices.

Your responsibilities :

Compliance (Technical & Medical)

Own all technical documentation related to product compliance (e.g., FCC, CE, RoHS, ISO 13485).

  • Prepare and maintain product technical files and declarations of conformity.
  • Coordinate product testing and certification with accredited labs and regulatory bodies.
  • Monitor and interpret evolving compliance standards (including FDA Class I / II if applicable).
  • Ensure compliance with risk management standards (e.g., ISO 14971).

Manufacturing Oversight

  • Serve as the primary point of contact for contract manufacturers.
  • Track production runs, yields, and quality issues; escalate and resolve when needed.
  • Oversee quality inspection procedures and first article testing.
  • Collaborate with engineering on manufacturability and NPI (New Product Introduction).
  • Support root cause analysis and corrective actions for production issues.

    • Cross-Functional Collaboration

  • Partner with Product, Design, and Engineering teams to ensure DFM (Design for Manufacturability) and regulatory readiness.
  • Assist with internal and external audits as needed.
  • Help drive process improvements across quality, compliance, and manufacturing workflows.

    • About You :

  • 3–5 years experience in hardware engineering, regulatory compliance, or manufacturing operations for consumer electronics, medical devices, or health tech.
  • Proven experience with regulatory compliance standards :

    • Mandatory : CE, FCC, RoHS

  • Strongly Preferred : ISO 13485, ISO 14971, FDA Class I / II understanding
  • Experience working with contract manufacturers or ODMs (domestic or overseas).
  • Strong organizational skills and ability to manage compliance documentation (QMS, risk files, test reports).
  • Working knowledge of hardware design, quality control processes, and manufacturing workflows.
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    Hardware Engineer • San Diego, United States