Senior Device Engineer

Position Summary

The Senior Device Engineer is responsible for leading all CGMP combination product manufacturing technical activities from clinical through to commercial launch at CMO. As a hands-on technical lead/contributor and device subject matter expert (SME), this person will provide project and engineering leadership in the concept, feasibility, development, qualification and launch phases of device development. Collaborate closely with vendors, CMO, CLO, CMC, QA, RA, and subject matter experts to advance the company’s product pipeline on schedule and in alignment with corporate expectations. In this position, you will need to provide scientific and technical judgment as part of a team responsible for delivering high quality biopharmaceutical products to patients. Integrity, accountability, and strong dedication to the patients we serve are critical to this role.

Essential Duties and Qualifications

• Area of focus will include identification of user needs, specification development, test development, design verification and validation testing, design transfer, risk management activities in alignment with device related quality management system (QMS) processes, as well as US regulations (e.g. 21 CFR 820.30), US FDA Guidance (e.g. Design Control Guidance), and applicable recognized international standards. Extensive collaboration with internal and external partners.
• This key technical role is responsible for change controls, manufacturing process validation, human factors, regular review of DHF, combination product launch activities, device product complaints, and post-market surveillance. This role interacts with external contract labs and contract manufacturing organizations and vendors, works closely with quality, regulatory, program leadership, etc. and establishes strategic working relationships.
• Provide technical leadership and contribution on cross functional teams for devices through clinical development, product registration and commercialization. Own and lead the creation of design control deliverables to comply with combination device regulations.
• Lead project execution activities and oversee the development of statistically sound design verification protocols/reports and design validation.
• Provide solid understanding of polymeric device manufacturing processes via molding and assembly, and solid knowledge of global standards for the combination products.
• Characterize critical process parameters (CPPs) and critical quality attributes (CQAs) using QbD principles, risk assessments, and DoE.
• Supports and aligns all clinical and commercial regulatory activities and authoring related to combination product and device development, including (not limited to): NDA, IND/IMPD, 510K Submission, BLA and IRs.
• Provide technical expertise and mentorship for the organization. Foster a collaborative environment to promote innovation and problem-solving.
• This role contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.
• Establishes and assures adherence to budgets, schedules, work plans and performance requirements.
• Manage project workloads to provide innovative technical solutions to meet project deadlines.
• Ensures budgets, schedules and performance requirements are met.
• Travel to contract manufacturers or businesses partners, as required, up to 20%

Skills and Experience:

• Must have experience in device development, qualification and launch phases for combination products.

• Must have 7+ years of industry experience with a minimum of at least  3 years of experience in a CGMP pharmaceutical manufacturing or other regulated setting is required.

• Experience supporting regulated devices / combination products under Design Control (21 CFR 820), ISO13485, ISO14791 and IEC62366 requirements.

• Must have a thorough working knowledge of FDA, ISO and cGMP requirements for areas of responsibilities.
• Background and experience in combination product development and commercialization strongly preferred.
• Strong verbal and written communication skills are required.
• Must be goal-oriented, quality-conscientious, and customer focused.
• Maintaining high standards of safety and compliance is a must.
• Must be experienced in working in a team-focused environment.
• Pre-filled syringe experience is a plus.

Education:

Bachelor’s degree in a scientific or engineering field and 7+ years of experience, or an advanced degree (MS/PhD) with proportional experience.