New Product Development Engineer
Akkodis
Akkodis is seeking a New Product Development Engineer for a client located in Carlsbad, CA. This is a 12-month contract Position. Ideally looking for a candidate with experience in Medical Device Manufacturing Industry.
Pay Range: $55 - $70/hour; The rate may be negotiable based on experience, education, geographic location, and other factors
Your Responsibilities will Include
- Lead and apply advanced, systematic problem-solving methodologies to resolve complex product and process quality issues across the product lifecycle.
- Provide senior-level quality engineering leadership on cross-functional new product development teams, ensuring robust design inputs, verification and validation strategies and regulatory compliance.
- Drive the implementation and continuous improvement of risk management activities, including hazard analysis, fault tree analysis and FMEAs, ensuring alignment with ISO 14971 and internal standards.
- Develop and approve verification and validation protocols and reports, applying advanced statistical techniques and ensuring compliance with global regulatory requirements.
- Establish, review and maintain Design History File documentation, including design requirements, specifications and design outputs, ensuring inspection readiness.
- Lead design change control activities, assessing product and process impacts while ensuring compliance and patient safety.
- Monitor field performance of new and established medical devices, analyze trends against risk assessments and drive corrective and preventive actions as needed.
- Mentor junior engineers and contribute to the development of best practices that elevate team capability and performance.
Required qualifications
- Bachelor of Science degree in Engineering or a related technical field.
- Minimum of 7 years' experience in quality engineering or design assurance within the medical device industry.
- Demonstrated expertise in risk management, design controls and product verification and validation.
- Strong knowledge of global quality system regulations and standards, including ISO 13485 and ISO 14971.
- Proven ability to lead cross-functional initiatives and influence stakeholders at multiple organizational levels.
- Strong written and verbal communication skills.
- Ability to manage multiple priorities and navigate ambiguity in a fast-paced environment.
- Degree in biomedical or mechanical engineering.
- Experience supporting structural heart, cardiovascular or implantable medical devices.
- Certification in quality engineering (e.g., CQE) or related credential.
- Demonstrated use of advanced quality tools and statistical methodologies.
- Passion for continuous improvement, talent development and building high-performing teams.
If you are interested in this role, then please click APPLY NOW. For other opportunities available at Akkodis, or any questions, please contact Punit Pathak at 610 445 8219 or ***email_hidden***.
Equal Opportunity Employer/Veterans/Disabled
Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, an EAP program, commuter benefits, and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs that are direct hires to a client.
To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.akkodis.com/en/privacy-policy
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