Saracasolutions
Senior Sustaining Engineer (On-site – Carlsbad, CA)
Saracasolutions, Carlsbad, California, United States, 92002
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Hiring | MedTech & Engineering Hiring | Strategic Hiring | Stakeholder Management
We are seeking a highly experienced and motivated
R&D Sustaining Engineer
to support upcoming product launches while maintaining and improving existing products post-launch. This role ensures regulatory compliance, supports manufacturing and quality teams, and drives cost and performance improvements. Key Responsibilities: Provide R&D support for released products, addressing design, manufacturing, and quality issues. Lead design improvements and component substitutions while maintaining regulatory compliance. Conduct root cause analysis and implement corrective & preventive actions (CAPA). Update technical documentation (drawings, specifications, risk assessments). Collaborate across R&D, Quality, Regulatory, and Manufacturing teams. Ensure products meet
FDA ,
ISO 13485 , and other relevant standards. Work with suppliers to resolve component issues and qualify new parts. Qualifications: Bachelor’s or Master’s degree in Mechanical, Biomedical, Electrical, or related engineering. 5–7+ years of experience in
medical device engineering , preferably with single-use disposable catheters for coronary/peripheral vasculature procedures. Strong knowledge of
design controls, risk management, and regulatory requirements . Proficiency in CAD tools, statistical analysis, and root cause methodologies (8D, Fishbone, FMEA). Excellent problem-solving and communication skills. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Contract Job function
Job function Quality Assurance Referrals increase your chances of interviewing at SARACA by 2x Sign in to set job alerts for “Sustaining Engineer” roles.
Carlsbad, CA $90,000.00-$100,000.00 5 days ago Carlsbad, CA $80,000.00-$95,000.00 4 days ago Fallbrook, CA $80,000.00-$115,000.00 1 month ago Product Development Engineer (Medical Device)
Carlsbad, CA $95,000.00-$150,000.00 1 day ago Carlsbad, CA $88,252.50-$110,187.50 4 days ago Carlsbad, CA $68,640.00-$96,300.00 2 weeks ago Manufacturing/Operations Quality Engineer
Carlsbad, CA $120,000.00-$135,000.00 3 weeks ago Carlsbad, CA $98,000.00-$126,000.00 1 week ago Carlsbad, CA $115,000.00-$135,000.00 6 days ago Carlsbad, CA $104,656.00-$179,411.00 2 weeks ago San Clemente, CA $45.00-$55.00 3 weeks ago Poway, CA $80,000.00-$100,000.00 4 weeks ago Carlsbad, CA $120,000.00-$140,000.00 1 month ago Carlsbad, CA $98,661.00-$157,659.00 10 hours ago Vista, CA $85,000.00-$95,000.00 5 days ago Carlsbad, CA $115,000.00-$135,000.00 10 hours ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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We are seeking a highly experienced and motivated
R&D Sustaining Engineer
to support upcoming product launches while maintaining and improving existing products post-launch. This role ensures regulatory compliance, supports manufacturing and quality teams, and drives cost and performance improvements. Key Responsibilities: Provide R&D support for released products, addressing design, manufacturing, and quality issues. Lead design improvements and component substitutions while maintaining regulatory compliance. Conduct root cause analysis and implement corrective & preventive actions (CAPA). Update technical documentation (drawings, specifications, risk assessments). Collaborate across R&D, Quality, Regulatory, and Manufacturing teams. Ensure products meet
FDA ,
ISO 13485 , and other relevant standards. Work with suppliers to resolve component issues and qualify new parts. Qualifications: Bachelor’s or Master’s degree in Mechanical, Biomedical, Electrical, or related engineering. 5–7+ years of experience in
medical device engineering , preferably with single-use disposable catheters for coronary/peripheral vasculature procedures. Strong knowledge of
design controls, risk management, and regulatory requirements . Proficiency in CAD tools, statistical analysis, and root cause methodologies (8D, Fishbone, FMEA). Excellent problem-solving and communication skills. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Contract Job function
Job function Quality Assurance Referrals increase your chances of interviewing at SARACA by 2x Sign in to set job alerts for “Sustaining Engineer” roles.
Carlsbad, CA $90,000.00-$100,000.00 5 days ago Carlsbad, CA $80,000.00-$95,000.00 4 days ago Fallbrook, CA $80,000.00-$115,000.00 1 month ago Product Development Engineer (Medical Device)
Carlsbad, CA $95,000.00-$150,000.00 1 day ago Carlsbad, CA $88,252.50-$110,187.50 4 days ago Carlsbad, CA $68,640.00-$96,300.00 2 weeks ago Manufacturing/Operations Quality Engineer
Carlsbad, CA $120,000.00-$135,000.00 3 weeks ago Carlsbad, CA $98,000.00-$126,000.00 1 week ago Carlsbad, CA $115,000.00-$135,000.00 6 days ago Carlsbad, CA $104,656.00-$179,411.00 2 weeks ago San Clemente, CA $45.00-$55.00 3 weeks ago Poway, CA $80,000.00-$100,000.00 4 weeks ago Carlsbad, CA $120,000.00-$140,000.00 1 month ago Carlsbad, CA $98,661.00-$157,659.00 10 hours ago Vista, CA $85,000.00-$95,000.00 5 days ago Carlsbad, CA $115,000.00-$135,000.00 10 hours 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