Bolt Medical
This range is provided by Bolt Medical. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
$115,000.00/yr - $135,000.00/yr Direct message the job poster from Bolt Medical DIRECT CANDIDATES ONLY, IF INTERESTED APPLY THROUGH JOB POST. NO DIRECT MESSAGES. RECRUITERS: DO NOT CONTACT. Position Overview:
We are seeking a highly experienced and motivated R&D Sustaining Engineer to help us support our upcoming product launches as well as maintaining and improving existing products post-launch. This role ensures continued compliance with regulatory standards, supports manufacturing and quality teams, and drives cost and performance improvements. The ideal candidate will have a minimum of 3 years of experience in the medical device industry, particularly in catheter technology. Responsibilities: Product Support: Provide R&D support for released products, addressing design, manufacturing, and quality issues. Change Management: Lead design improvements, and component substitutions while maintaining regulatory compliance. Root Cause Analysis: Investigate product failures and implement corrective and preventive actions (CAPA). Documentation: Update technical documentation including drawings, specifications, and risk assessments. Cross-functional Collaboration: Work with R&D, Quality, Regulatory, and Manufacturing teams to resolve issues and implement changes. Regulatory Compliance: Ensure products meet FDA, ISO 13485, and other applicable standards. Supplier Interaction: Collaborate with suppliers to resolve component issues and qualify new parts. Qualifications: Bachelor’s or Master’s degree in Engineering (Mechanical, Biomedical, Electrical, etc.) 5-7+ years of experience in medical device engineering, preferably single-use disposables catheters used in coronary and peripheral vasculature procedures. Strong knowledge of design controls, risk management, and regulatory requirements. Experience with CAD tools, statistical analysis, and root cause methodologies (e.g., 8D, Fishbone, FMEA). Excellent problem-solving and communication skills. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Quality Assurance Industries Medical Equipment Manufacturing Referrals increase your chances of interviewing at Bolt Medical by 2x Inferred from the description for this job
Medical insurance Vision insurance 401(k) Get notified about new Sustaining Engineer jobs in
Carlsbad, CA . Carlsbad, CA $90,000.00-$100,000.00 1 week ago San Marcos, CA $82,000.00-$100,000.00 1 month ago Fallbrook, CA $80,000.00-$115,000.00 1 month ago Carlsbad, CA $88,252.50-$110,187.50 5 days ago Carlsbad, CA $120,000.00-$135,000.00 1 week ago Product Development Engineer (Medical Device)
Carlsbad, CA $110,000.00-$150,000.00 3 weeks ago Carlsbad, CA $68,640.00-$96,300.00 2 weeks ago San Marcos, CA $82,000.00-$100,000.00 1 month ago Carlsbad, CA $98,000.00-$126,000.00 1 week ago San Marcos, CA $96,000.00-$118,000.00 1 month ago Carlsbad, CA $110,000.00-$125,000.00 1 month ago Poway, CA $68,770.00-$116,193.00 1 day ago Carlsbad, CA $120,000.00-$140,000.00 3 weeks ago Carlsbad, CA $115,000.00-$135,000.00 2 days ago Carlsbad, CA $150,000.00-$170,000.00 4 weeks ago Carlsbad, CA $80,000.00-$90,000.00 4 weeks ago Senior Product Development Engineer - Medical Devices
Carlsbad, CA $100,000.00-$140,000.00 3 weeks ago Carlsbad, CA $110,000.00-$140,000.00 3 weeks ago Vista, CA $85,000.00-$95,000.00 1 week ago Poway, CA $91,000.00-$100,000.00 2 weeks ago Carlsbad, CA $98,661.00-$157,659.00 1 day 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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$115,000.00/yr - $135,000.00/yr Direct message the job poster from Bolt Medical DIRECT CANDIDATES ONLY, IF INTERESTED APPLY THROUGH JOB POST. NO DIRECT MESSAGES. RECRUITERS: DO NOT CONTACT. Position Overview:
We are seeking a highly experienced and motivated R&D Sustaining Engineer to help us support our upcoming product launches as well as maintaining and improving existing products post-launch. This role ensures continued compliance with regulatory standards, supports manufacturing and quality teams, and drives cost and performance improvements. The ideal candidate will have a minimum of 3 years of experience in the medical device industry, particularly in catheter technology. Responsibilities: Product Support: Provide R&D support for released products, addressing design, manufacturing, and quality issues. Change Management: Lead design improvements, and component substitutions while maintaining regulatory compliance. Root Cause Analysis: Investigate product failures and implement corrective and preventive actions (CAPA). Documentation: Update technical documentation including drawings, specifications, and risk assessments. Cross-functional Collaboration: Work with R&D, Quality, Regulatory, and Manufacturing teams to resolve issues and implement changes. Regulatory Compliance: Ensure products meet FDA, ISO 13485, and other applicable standards. Supplier Interaction: Collaborate with suppliers to resolve component issues and qualify new parts. Qualifications: Bachelor’s or Master’s degree in Engineering (Mechanical, Biomedical, Electrical, etc.) 5-7+ years of experience in medical device engineering, preferably single-use disposables catheters used in coronary and peripheral vasculature procedures. Strong knowledge of design controls, risk management, and regulatory requirements. Experience with CAD tools, statistical analysis, and root cause methodologies (e.g., 8D, Fishbone, FMEA). Excellent problem-solving and communication skills. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Full-time Job function
Job function Quality Assurance Industries Medical Equipment Manufacturing Referrals increase your chances of interviewing at Bolt Medical by 2x Inferred from the description for this job
Medical insurance Vision insurance 401(k) Get notified about new Sustaining Engineer jobs in
Carlsbad, CA . Carlsbad, CA $90,000.00-$100,000.00 1 week ago San Marcos, CA $82,000.00-$100,000.00 1 month ago Fallbrook, CA $80,000.00-$115,000.00 1 month ago Carlsbad, CA $88,252.50-$110,187.50 5 days ago Carlsbad, CA $120,000.00-$135,000.00 1 week ago Product Development Engineer (Medical Device)
Carlsbad, CA $110,000.00-$150,000.00 3 weeks ago Carlsbad, CA $68,640.00-$96,300.00 2 weeks ago San Marcos, CA $82,000.00-$100,000.00 1 month ago Carlsbad, CA $98,000.00-$126,000.00 1 week ago San Marcos, CA $96,000.00-$118,000.00 1 month ago Carlsbad, CA $110,000.00-$125,000.00 1 month ago Poway, CA $68,770.00-$116,193.00 1 day ago Carlsbad, CA $120,000.00-$140,000.00 3 weeks ago Carlsbad, CA $115,000.00-$135,000.00 2 days ago Carlsbad, CA $150,000.00-$170,000.00 4 weeks ago Carlsbad, CA $80,000.00-$90,000.00 4 weeks ago Senior Product Development Engineer - Medical Devices
Carlsbad, CA $100,000.00-$140,000.00 3 weeks ago Carlsbad, CA $110,000.00-$140,000.00 3 weeks ago Vista, CA $85,000.00-$95,000.00 1 week ago Poway, CA $91,000.00-$100,000.00 2 weeks ago Carlsbad, CA $98,661.00-$157,659.00 1 day 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