Our client is seeking a Senior Device Engineer responsible for device lifecycle management of on-market medical devices and combination products. This role develops change management technical impact assessments, design and development plans, risk management and design verification plans, test methods, and data analyses, and ensures design controls are documented in accordance with internal procedures.
Responsibilities
- Lead device and manufacturing process changes, including documentation and risk file updates, to ensure there is no adverse impact to the patient/user and that device design integrity is maintained.
- Serve as liaison between device engineering lifecycle management and internal production sites, Regulatory, and Quality colleagues.
- Lead design change projects according to internal procedures, track progress, and communicate status to group leadership.
- Establish experimental protocols, conduct experiments, and analyze results.
- Lead technical execution of Design History File (DHF) updates.
- Establish and maintain relationships with internal production site colleagues.
- Support Manufacturing and Quality Assurance in the disposition of Non-Conforming Reports and the qualification of materials, processes, and changes to ensure reliability requirements are met, with guidance and supervision.
- Establish and review specifications and requirements for components, products, and processes, with guidance and supervision.
- Support CAPA and complaint investigations, as appropriate.
- Collaborate regularly with Quality Assurance, Quality Operations, Safety, Medical Affairs, Regulatory Affairs, and production site teams across all functions.
Qualifications
- Bachelor’s degree or Master’s degree in Mechanical or Biomedical Engineering.
- 8+ years of prior experience in medical device or combination product design controls, production, sustaining engineering, or quality.
- Strong knowledge and experience in device design control, risk management, medical devices, and combination products.
- Experience analyzing patient/user impact.
- Experience in a GMP-regulated industry.
- Understanding and practical knowledge of 21 CFR Part 820, ISO 13485, ISO 14971, and related standards.
- Critical thinking and problem-solving skills.
- Ability to work independently as well as a member of a team in a fast-paced environment.
- Working knowledge of statistical methods for data analysis.
- Experience with Computer-Aided Design (CAD) software.
Location
Employee Type
Compensation & Benefits
- Hourly rate $70-95 depending on experience
- Medical and dental insurance
- Paid time off
- 401(k) after 90 days
About Ventura Solutions
Ventura Solutions is a reputable end-to-end medical device and combination product consulting, staffing, and training firm. With our deep industry expertise spanning medical devices and combination products, coupled with an outstanding talent pool, we stand out as the preferred option for a diverse array of projects. On the consulting side, we integrate seamlessly into your team and manage small to complex Statement of Work (SOW) projects. On the staffing side, we help source, screen, and on-board reputable employees to fill temporary, temp to permanent, and permanent job openings. We accelerate product development, keep products compliant, and help build great organizations. For more information, visit us at www.ventura-solutions.com.
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