BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
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. Come join our team and make a meaningful impact on patients' lives.
SUMMARY DESCRIPTION The Associate Engineer, Technical Services 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 Sr. Engineer, Technical Services may 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 all stages of design control for class II/III medical devices. • Interface with key stakeholders and outside experts / vendors to define project / product requirements. • 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. for 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. • May lead and coordinate human factor engineering studies. • May facilitate product and process improvement thru appropriate change controls and documentation. • May participate in the identification, evaluation and selection of technology and service providers, and contract manufacturers. • Facilitate issue resolution and problem solving for medical devices. • Knowledge of regulations and standards (e.g. cGMP/QSR/ICH/ISO/AAMI/ANSI/FDA/EMA).
LOCATION: Novato, California
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 2-3 years related experience in medical device / combination product development.
EXPERIENCE • 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. • 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, Formulations, 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.