Senior Engineer II, Device and Combination Products

3 weeks ago

Novato, United States BioSpace, Inc. Full time
Job Details

The Medical Device and Combination Products DPDT Engineer (Sr Engineer 2 Level 8) is responsible for development of medical device components of drug-device combination products. Primary activity is to manage and support design control, risk management and human factor engineering. The Engineer will lead internal device teams and will represent BioMarin to interact with technology and service providers, and contract manufacturers (CMOs) to ensure that all required activities are defined clearly and performed in a timely manner.

RESPONSIBILITIES
  • Create and own technical documentation (e.g. testing protocols, reports, SOPs, work instructions, etc.)
  • Acquire laboratory equipment and instruments.
  • Manage / support device development and post-marketing activities, including regulatory activities.
  • Provide device related product support for all Device related commercial products at BioMarin and Liaise across BioMarin sites and departments.
  • Own complaints process for all device and combination products within BioMarin and Provide Technical Support for Device product investigations.
  • Support all regulatory filings and new market indications including authoring of device sections.
  • 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 BioMarin's Pipeline portfolio.
  • Create design control documentations such as Design and Development Plan, User Requirements, Design Verification Plan, Design Validation Plan etc.
  • 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.
  • Lead and coordinate human factor engineering studies with clinical sciences group.
  • Facilitate product and process improvement thru appropriate change controls and documentation.
  • Lead the identification, evaluation and selection of new device technology, service providers, and contract manufacturers.
  • Knowledge of regulations and standards (e.g. cGMP/QSR/ICH/ISO/AAMI/ANSI/FDA/EMA)
  • Working knowledge of design software packages e.g. SolidWorks an advantage.

    LOCATION
    United States (Novato, California) Hybrid

    SCOPE
    This person will mainly be focused on ensuring Device Development activities to be performed per Regulatory guidance, industry practices and BioMarin's SOPs. He/she will lead, support, and coordinate between various internal functions as well as external parties to ensure that devices / combination products meet predefined requirements.

    EDUCATION
    University degree in Engineering or related scientific discipline preferred, with 8-10 years related experience in medical device / combination product development.
  • University degree in Engineering or related scientific discipline preferred. PhD with 2+ years experience in engineering or MS with 8+ years or BS with 10+ years experience.

    EXPERIENCE
  • Experience managing cross functional programs is highly desirable.
  • Experience leading and coordinating human factor engineering studies
  • Experience to work in an out-sourced environment and to work with contract research, development, and manufacturing organizations is highly desirable.
  • Excellent written and verbal communication skills.
  • Must be comfortable with leading without authority, uncertainty and change.
Travel: Up to 20%

CONTACTS
Internally this person will need to interact with Clinical Operations, Clinical Sciences, Compliance, Contract Manufacturing, Drug Product development, Legal, Marketing, Product Management, Project Management, Quality Assurance, Quality Control, Regulatory, and Validation. The successful candidate will also be one of the main contacts for third party providers such as technology providers and contract manufacturers. The successful candidate will be responsible for optimizing the inclusion and contributions from cross functional teams.

SUPERVISOR RESPONSIBILITY
This position could supervise others including associates, contractors and consultants.
BioMarin is an an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Who We Are

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.

Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.

Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.

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