1754-1 Project Engineer

1754-1 Project Engineer San Rafael, CA ABOUT

TECHNICAL OPERATIONS

The 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 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 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 the company 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

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 the company's 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. As needed, facilitate product and process improvement through appropriate change controls and documentation. Knowledge of regulations and standards (e.g.c

GMP/QSR/ICH/ISO/AAMI/ANSI/FDA/EMA

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

SCOPE:

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

DESIRED SKILLS

Device development, combination product development, auto injector, prefilled syringe, needle safety device, on body injector, on body device, vial and syringe development. Design history file, risk management (dfmea, ufmea, pfmea), design traceability matrix, design verification, design validation, process development. Design verification testing, report writing. Developing test methods. Design for assembly, design for manufacturability. Design input requirements, user requirements. Design output specification. Experience in working with external device component companies, vendors and CDMOs. The hiring range for this position is $90.00 to $103.44 per hour. The base pay actually offered will take into account internal equity, and may also vary depending on candidate's geographic region, job-related knowledge, skills, and experience amongst other factors. Harvest Technical Services is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, pregnancy, disability, age, veteran status, or any other federal, state, or local protected class.