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Medical Device and Combination Products Engineer

Joulé

Novato, CA

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JOB DETAILS
SALARY
$100–$103.45 Per Hour
LOCATION
Novato, CA
POSTED
11 days ago
Job Title: Medical Device and Combination Products Engineer
Location: Novato, CA
Contractor Work Model: Hybrid (Tues, Weds, Thurs on-site)
Hours: M-F normal business hours
Compensation: $100-$103.45
Type: Contract, Potential for extension or conversion to permanent

Responsibilities
  • Drive device and combination product development related engineering activities on critical pipeline products. This includes component and sub-assembly design, creating design history files, and leading technical project team meetings.
  • Create and own technical documentation (e.g., testing protocols, reports, SOPs, work instructions, etc.).
  • Manage/support device development including regulatory activities.
  • Support all regulatory filings and related activities.
  • Manage/support all stages of design control for class II/III medical devices.
  • Interface with key stakeholders and outside experts/vendors to define project/product requirements to meet company Pipeline portfolio.
  • Specify test requirements and acceptance criteria to satisfy quality and regulatory needs (e.g., Design Verification Testing, DVT).
  • Lead/support risk analyses, such as hazard identification, FTA, FMEA, etc., associated with devices.
  • Provide support to device component manufacturing and final product assembly with CMO.
  • Support human factor engineering studies with clinical sciences group.
  • Facilitate product and process improvement through appropriate change controls and documentation as needed.
  • Maintain knowledge of regulations and standards (e.g., cGMP/QSR/ICH/ISO/AAMI/ANSI/FDA/EMA).
  • Utilize design software packages such as SolidWorks (advantageous).

Requirements
  • University degree in Engineering or related scientific discipline preferred, with 8-10 years related experience in medical device / combination product development.
  • Experience managing cross-functional programs is highly desirable.
  • Experience leading and coordinating human factor engineering studies.
  • Experience working in an outsourced environment with contract research, development, and manufacturing organizations is highly desirable.
  • Excellent written and verbal communication skills.
  • Comfortable leading without authority, managing uncertainty, and adapting to change.
  • Knowledge of device development, combination product development, auto injectors, prefilled syringes, needle safety devices, on-body injectors, vial and syringe development.
  • Experience with design history files, risk management (DFMEA, UFMEA, PFMEA), design traceability, verification, validation, and process development.
  • Ability to develop test methods and reports, and experience in design for assembly and manufacturability.
  • Experience working with external device component companies, vendors, and CDMOs.

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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Ref: #558-Scientific


About the Company

J

Joulé

With extensive scientific, clinical, and healthcare industry experience, Joulé recruiters excel at placing talent across core specialty areas:

  • Scientific staffing for hard-to-find skills

Working across every scientific discipline, Joulé places biologists, chemists, scientists, technicians and other specialists.

  • Clinical lifecycle recruiting

From research to regulations, safety to statistics, Joulé helps clients manage every stage of the clinical development lifecycle.

  • Equipment calibration, maintenance and validation

Laboratory and facility support comes with a total quality commitment backed by ISO 9001:2008 certification.

  • National healthcare recruitment

Trust Joulé’s extensive experience in physician, advanced practice provider and executive direct placement search.

COMPANY SIZE
500 to 999 employees
INDUSTRY
Biotechnology/Pharmaceuticals
WEBSITE
https://www.jouleinc.com/