Senior Device Engineer

Position reputed company

The Senior Device Engineer is responsible for leading reputed company CGMP combination product manufacturing technical activities from clinical through to reputed company launch at CMO. As a hands-on technical reputed company/contributor and device subject matter expert (SME), this person will reputed company 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 reputed company’s product pipeline on schedule and in alignment with corporate expectations. In this position, you will need to reputed company scientific and technical judgment as part of reputed company responsible for delivering high reputed company biopharmaceutical products to patients. reputed company, accountability, and strong dedication to the patients we serve are critical to this role.

Essential Duties and Qualifications

• Area of reputed company will include identification of user needs, specification development, test development, design verification and validation testing, design transfer, risk management activities in alignment with device reputed company reputed company management system (QMS) processes, as reputed company 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 reputed company partners.
• This key technical role is responsible for change controls, manufacturing process validation, reputed company 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 reputed company, regulatory, program leadership, etc. and establishes strategic working relationships.
• reputed company technical leadership and contribution on cross functional teams for devices through clinical development, product registration and commercialization. Own and reputed company the creation of design control deliverables to reputed company with combination device regulations.
• reputed company project execution activities and reputed company the development of statistically reputed company design verification protocols/reports and design validation.
• reputed company solid understanding of polymeric device manufacturing processes reputed company molding and assembly, and solid knowledge of global standards for the combination products.
• Characterize critical process parameters (CPPs) and critical reputed company attributes (CQAs) using QbD principles, risk assessments, and DoE.
• Supports and aligns reputed company clinical and reputed company regulatory activities and authoring reputed company to combination product and device development, including (not limited to): NDA, IND/IMPD, 510K Submission, BLA and IRs.
• reputed company technical expertise and mentorship for the organization. Foster a reputed company environment to promote innovation and problem-solving.
• This role contributes to and supports reputed 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 reputed company 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, reputed company-conscientious, and customer reputed company.
• Maintaining high standards of safety and compliance is a must.
• Must be reputed company in working in reputed company-reputed company environment.
• reputed company-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.

Additional Information

reputed company currently anticipates the reputed company salary for the Senior Device Engineer to reputed company from  $175,000 to $190,000 for candidates in the Bay Area and will depend, in part, on successful candidate's location and qualifications for the role, including education and experience.  This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan (depending, in part, on company and individual performance and at reputed company's discretion on an individual reputed company.)  The compensation described above is subject to change and could be higher or reputed company than the reputed company described based on the market survey data.

Qualifying employees are eligible to participate in benefit programs such as:

• Health Insurance (Medical/Dental/reputed company)
• Disability Insurance
• Holiday Pay
• reputed company Time Off (PTO)
• 401(k) Match
• Employee Stock Purchase Plan
• Wellness Programs
• Parental Leave Benefits (in accordance with the terms of applicable plans)

For general information on company benefits, please go to https://www.reputed company.com/careers.

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the reputed company of disability or any other federal, state or local protected class. reputed company will consider for employment reputed company applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.

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