Description

Who We Are

BioMarin’s 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 BioMarin’s 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.

SUMMARY
The Medical Device and Combination Products MSAT Engineer (Senior) 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 tasks.  The Senior 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

• Manage / Support device development and post-marketing activities, including regulatory 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 BioMarins 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 DV, Process Validation PV).
• Lead / support risk analyses, such as hazard identification, FTA, FMEA etc., associated with devices.
• Manage device component manufacturing and final product assembly with 3^rd party CMO.
• Lead and coordinate human factor engineering studies with clinical sciences group.
• Facilitate product and process improvement through appropriate change controls and documentation.
• Participate in the identification, evaluation and selection of technology and service providers, and contract manufacturers.
• Provide Technical Support for Device product investigations and complaints.
• Demonstrate sound knowledge of regulations and standards (e.g. cGMP/QSR/ICH/ISO/AAMI/ANSI/FDA/EMA/21 CFR/ASTM)
• Working knowledge of design software packages e.g. SolidWorks an advantage.

LOCATION
IRL (Dublin / Cork) Hybrid

SCOPE
This person will ensure Device Development activities are 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. This person will also provide commercial support to manufacturing at our European based CMO’s

EXPERIENCE

• Bachelor’s degree (BS) in mechanical engineering or biomechanical engineering; MS is preferred
• 8+ years of relevant experience in the medical device industry and/or post-graduate academia (or equivalent)
• Proficiency with mechanical CAD software and strong knowledge of solid modeling (preferably Solidworks) familiarity with MATLAB is a plus
• Experience with system testing and V&V
• Involvement and management of external partners and/or third-party contract vendors
• Ability to work independently in a fast-paced and collaborative multidisciplinary setting
• Excellent oral and written communication
• Strong problem-solving skills and organization

 

• Working knowledge of medical device / combination product development.
• Experience managing cross functional programs is highly desirable.
• Experience to work in an out-sourced environment and to work with contract research, development, and manufacturing organizations is highly desirable.
• Travel: Up to 20%
  
  

CONTACTS
Internally this person will need to interact with Clinical Operations, Clinical Sciences, Compliance, Contract Manufacturing, Formulations, Legal, Marketing, Product Management, Project Management, Quality Assurance, Quality Control, Regulatory, and Validation. The Candidate will be reporting directly to the Associate Director of Medical Device and Combination Products MSAT. 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 engineers, contractors and consultants.

We are 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.