Panthr
Hardware Compliance & Manufacturing Engineer
Panthr, San Diego, California, United States, 92189
Hardware Compliance & Manufacturing Engineer
Join to apply for the
Hardware Compliance & Manufacturing Engineer
role at
Panthr Hardware Compliance & Manufacturing Engineer
1 month ago Be among the first 25 applicants Join to apply for the
Hardware Compliance & Manufacturing Engineer
role at
Panthr @ 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
Manufacturing Oversight
Cross-Functional Collaboration
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). 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. 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.
Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Administrative, Engineering, and Manufacturing Industries Wellness and Fitness Services Referrals increase your chances of interviewing at Panthr by 2x Get notified about new Manufacturing Engineer jobs in
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#J-18808-Ljbffr
Join to apply for the
Hardware Compliance & Manufacturing Engineer
role at
Panthr Hardware Compliance & Manufacturing Engineer
1 month ago Be among the first 25 applicants Join to apply for the
Hardware Compliance & Manufacturing Engineer
role at
Panthr @ 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
Manufacturing Oversight
Cross-Functional Collaboration
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). 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. 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.
Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Administrative, Engineering, and Manufacturing Industries Wellness and Fitness Services Referrals increase your chances of interviewing at Panthr by 2x Get notified about new Manufacturing Engineer jobs in
San Diego, CA . San Diego, CA $68,770.00-$116,193.00 12 hours ago Tijuana, Baja California, Mexico 7 hours ago Sr. Mechanical Engineer (Must Have Injection Molded And Sheet Metal Part Design)
San Diego, CA $70,000.00-$80,000.00 1 year ago Quality Engineer III (PT position 20 hrs. week)
San Diego, CA $130,000.00-$155,000.00 20 hours ago Quality Engineer II - Onsite (Urgent Need)
Poway, CA $80,000.00-$100,000.00 1 month ago Tijuana, Baja California, Mexico 1 month ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr