Senior Medical Device Process Engineer

Abbott (abbottcareers2 board); United States; On-site; USD 90,000 - 180,000; Full time

Job summary

Abbott Diabetes Care in Alameda, CA seeks an engineering professional to design, verify and validate manufacturing processes for diabetes care products. You will troubleshoot equipment, develop specifications, and run PFMEAs, DOEs and validation reports to meet design control requirements.

Join a team focused on process development, cost-efficient manufacturing and regulatory compliance within an FDA-regulated environment.

Qualifications

• Bachelor's degree in Engineering/Technical Discipline or equivalent.
• 4+ years of related experience in engineering/manufacturing.
• Solid understanding of medical device design controls and regulatory requirements (ISO13485, FDA).
• Experience with development of processes in an FDA-regulated environment.

Responsibilities

• Specify, design, verify and validate new manufacturing processes and equipment, per medical regulatory standards.
• Troubleshoots process equipment and perform process optimization.
• Develops process/product specifications, conducts PFMEAs, DOEs, validation protocols/reports.
• Communicate effectively and participate on cross functional development teams.
• Conducts or participates in technical design reviews for process equipment and product design.
• Write and submit Engineering Change Orders, as required.
• Maintain effectiveness of the quality system.
• Develop and implement new processes, equipment, materials verification and validation.
• Follow approved Design Control procedures for process development per FDA guidelines.

Skills

Engineering principles

Regulatory knowledge

Process optimization

Cross-functional teamwork

Documentation writing

Problem solving

Statistical analysis

Design for manufacturing

Education

Bachelor's degree in Engineering/Technical Discipline

Master's degree

Job description

Abbott Diabetes Care in Alameda, CA seeks an engineering professional to design, verify and validate manufacturing processes for diabetes care products. You will troubleshoot equipment, develop specifications, and run PFMEAs, DOEs and validation reports to meet design control requirements.

Join a team focused on process development, cost-efficient manufacturing and regulatory compliance within an FDA-regulated environment.