Medical Device Design Quality Engineers

RESPONSIBILITIES:
A Kforce client is seeking to hire a Medical Device Design Quality Engineers in Carlsbad, California (CA).

Summary:
The client is a growing and established Medical Device Technology company in the Carlsbad, CA area is seeking a Medical Device Design Quality Engineer. We are working directly with the Hiring Manager on this search assignment. The company offers a competitive compensation package including base salary, annual bonus and stock/RSU's. This position is partial remote.

Responsibilities include:
* Will be part of a product development team, ensuring design controls are being appropriately carried out through new product development per internal SOPs and external standards as applicable
* Design, develop and validate test methods for design verification and manufacturing
* Medical Device Design Quality Engineers will travel to contract manufacturers to support process development from early pilot manufacturing through design transfer and process validation
* Develop and maintain the risk management file throughout the product lifecycle
* Review and develop design verification/validation protocols ensuring adherence to applicable standards and company policies
* Medical Device Design Quality Engineers will manage contract manufacturers for quality related DHF deliverables
* Manage approved supplier list
* Lead resolution of manufacturing issues for on-market product through final disposition (NCMR's, Deviations, CAPA, etc.)

REQUIREMENTS:
* Certifications such as ASQ CQE, and/or ISO 13485 would be a plus
* Lead Auditor certification is a plus
* 2-4 years of experience in a Quality Engineering role within the medical device Industry
* Experience with new product development and/or design control processes
* Bachelor's degree in Engineering such as Biotechnology, Computer Engineering, Biomedical, Mechanical, Electrical, or similar field
* Exceptional ability to communicate across functions and at different levels throughout the organization
* Understanding of risk management techniques (Hazard Analysis, FMEA) and ISO 14971
* Working knowledge of applied statistical techniques (Hypothesis testing, Measurement Systems Analysis, Design of Experiments)
* Working knowledge of root cause analysis and associated quality techniques (fishbone diagram, 5 why's, etc.)
* Working knowledge of quality systems and associated regulations (21CFR820, ISO 13485, ISO 9001, etc.

Nice to haves but not required:
* Previous experience through one or more product development cycles leading to a successful regulatory submission and product launch
* Experience with Reliability Engineering, Highly Accelerated Life Testing, and Highly Accelerated Stress Screening (HALT/HASS)
* Experience with statistical process control (SPC)
* Experienced in any of the following: Minitab, Solid works, R, and/or Python preferred
* Experience with electrical safety standards (IEC 60601) would be a plus
* Experience with the software development lifecycle (IEC 62304) and/or cloud-based applications would be a plus
* Previous start-up experience is a plus

The pay range is the lowest to highest compensation we reasonably in good faith believe we would pay at posting for this role. We may ultimately pay more or less than this range. Employee pay is based on factors like relevant education, qualifications, certifications, experience, skills, seniority, location, performance, union contract and business needs. This range may be modified in the future.

We offer comprehensive benefits including medical/dental/vision insurance, HSA, FSA, 401(k), and life, disability & ADD insurance to eligible employees. Salaried personnel receive paid time off. Hourly employees are not eligible for paid time off unless required by law. Hourly employees on a Service Contract Act project are eligible for paid sick leave.

Note: Pay is not considered compensation until it is earned, vested and determinable. The amount and availability of any compensation remains in Kforce's sole discretion unless and until paid and may be modified in its discretion consistent with the law.

This job is not eligible for bonuses, incentives or commissions.

Kforce is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.