(CW) Product Engineer / Medical Device and Combination Products Engineer(CONTRACT/TEMPORARY)

b'nnnnnnnn (CW) Product Engineer / Medical Device and Combination Products Engineer(CONTRACT/TEMPORARY) | BioMarin Corporatennnn n n nnntntntntntntntntntntntntntntntntntnnnnnnnnnnnnnnnnnnnnnn nn

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(CW) Product Engineer / Medical Device and Combination Products Engineer(CONTRACT/TEMPORARY)

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Location: San Rafael, United States

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Workstyle: Hybrid

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Apply

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Who We Are

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BioMarin is a leading, global rare disease biotechnology company focused on delivering medicines for people living with genetically defined conditions. Founded in 1997, the San Rafael, California-based company has a proven track record of innovation, with multiple commercial therapies and a strong clinical and preclinical pipeline. Using a distinctive approach to drug discovery and development, BioMarin seeks to unleash the full potential of genetic science by pursuing category-defining medicines that have a profound impact on patients..

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About Technical Operations

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Our manufacturing and process development teams manage the production of our therapies for clinical trials and commercial markets. These engineers, technicians, scientists and support professionals continually provide quality assurance and ensure we meet all regulatory standards. We have manufacturing facilities in Northern California and in Shanbally, Ireland. Additionally, our supply chain teams procure the goods and services needed to support manufacturing and worldwide distribution.

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CONTRACT ROLE APPROX 6 months

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• Hybrid Position - Tues. Wed and Thurs. onsite in Novato*

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About Technical Operations:

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BioMarinxe2x80x99s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarinxe2x80x99s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients.

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SUMMARY DESCRIPTION

The Medical Device and Combination Products 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.

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RESPONSIBILITIES

xe2x80xa2 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.

xe2x80xa2 Create and own technical documentation (e.g. testing protocols, reports, SOPs, work instructions, etc.)

xe2x80xa2 Manage / support device development including regulatory activities.

xe2x80xa2 Support all regulatory filings and related activities.

xe2x80xa2 Manage / Support all stages of design control for class II/III medical devices.

xe2x80xa2 Interface with key stakeholders and outside experts / vendors to define project / product requirements to meet BioMarinxe2x80x99s Pipeline portfolio.

xe2x80xa2 Specify test requirements and acceptance criteria to satisfy quality and regulatory needs (e.g. Design Verification Testing, DVT).

xe2x80xa2 Lead / support risk analyses, such as hazard identification, FTA, FMEA etc., associated with devices.

xe2x80xa2 Provide support to device component manufacturing and final product assembly with CMO.

xe2x80xa2 Support human factor engineering studies with clinical sciences group.

xe2x80xa2 As needed, facilitate product and process improvement through appropriate change controls and documentation.

xe2x80xa2 Knowledge of regulations and standards (e.g.cGMP/QSR/ICH/ISO/AAMI/ANSI/FDA/EMA)

xe2x80xa2 Working knowledge of design software packages e.g. SolidWorks an advantage.

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SCOPE

This person will mainly be focused on ensuring Device Development activities to be performed per Regulatory guidance, industry practices and BioMarinxe2x80x99s 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.

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EDUCATION

University degree in Engineering or related scientific discipline preferred, with 8-10 years related experience in medical device / combination product development.

xe2x80xa2 University degree in Engineering or related scientific discipline preferred. Prefer MS with 8+ years or BS with 10+ years' experience.

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EXPERIENCE

xe2x80xa2 Experience managing cross functional programs is highly desirable.

xe2x80xa2 Experience leading and coordinating human factor engineering studies

xe2x80xa2 Experience to work in an out-sourced environment and to work with contract research, development, and manufacturing organizations is highly desirable.

xe2x80xa2 Excellent written and verbal communication skills.

xe2x80xa2 Must be comfortable with leading without authority, uncertainty and change.

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Desired Skills:

xe2x80xa2 Device development, combination product development, auto injector, prefilled syringe, needle safety device, on body injector, on body device, vial and syringe development

xe2x80xa2 Design history file, risk management (dfmea, ufmea, pfmea), design traceability matrix, design verification, design validation, process development

xe2x80xa2 Design verification testing, report writing. Developing test methods

xe2x80xa2 Design for assembly, design for manufacturability

xe2x80xa2 Design input requirements, user requirements

xe2x80xa2 Design output specification

xe2x80xa2 Experience in working with external device component companies, vendors and CDMOs

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Manager is not interested in the following:

xe2x80xa2 Lab technicians

xe2x80xa2 Information technology engineers

xe2x80xa2 Quality or regulatory engineers

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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.

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Equal Opportunity Employer/Veterans/Disabled

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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.

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Recruitment Fraud Alert Notice

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Please be aware of fraud or scams from individuals, organizations and/or internet sites claiming to represent BioMarin in recruitment activities. We have an established recruitment process which is required for all posted positions by BioMarin prior to issuing an offer of employment. This BioMarin process requires formal interviews conducted live with personnel representing BioMarin and never requires payments or fees from job applicants. BioMarin does not conduct interviews via texting tools such as RingCentral.

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In the event you receive a suspicious email message about recruiting on behalf of BioMarin, unless it's from a BioMarin authorized recruiting partner, do not provide any personal information or pay any fees. Qualified and interested candidates should apply to current openings directly through this BioMarin website. BioMarin accepts no responsibility for any costs or charges incurred as a result of fraudulent activity.

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If you have lost money or provided your personal identifying information, please contact your bank and report the matter to the FBI via www.ic3.gov. We would also suggest you notify your local police department and monitor your credit.

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For more information on how to recognize and report phishing scams visit: https://consumer.ftc.gov/articles/how-recognize-and-avoid-phishing-scams or https://consumer.ftc.gov/consumer-alerts/2023/01/looking-job-scammers-might-be-looking-you

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Equal Opportunity Employer/Veterans/Disabled

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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.

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If you have a disability and believe you need a reasonable accommodation in order to search for a job opening or apply for a position, emailxc2xa0Applicant_accommodations@bmrn.comxc2xa0with your request.

nThis email address is not for general employment inquiries or correspondence. We will only respond to those requests that are related to the accessibility of the online application system due to a disability.

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BioMarin Pharmaceutical does not accept unsolicited resumes from recruiters or agencies and we will not be responsible for any fees related to resumes that are unsolicited. We handle all recruiting through our Talent Acquisition team xe2x80x93 please do not contact hiring managers directly. Agencies who wish to offer their services to BioMarin Pharmaceutical may contact us atxc2xa0talentacquisition@bmrn.com.

nApplicants, please do not use this email address to submit resumes xe2x80x93 if you do so, you will be redirected to apply through the website.

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Click here to review "EEO Is The Law" poster.xc2xa0Click here to review the Pay Transparency Nondiscrimination Statement.xc2xa0Click here to review the Notification of Employee Rights under Federal Labor Laws.

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