Biomedical Device Engineer (Biotech/Biopharma/Medical device)

Payrate: $35.00 - $42.00/hr.

Responsibilities:

Designing, developing, testing, and implementing medical devices, ensuring regulatory standards.

Engineers play a pivotal role in driving medical advancements by applying their technical expertise and creativity to develop innovative solutions

Experience with medical devices, combination products, drug delivery devices, syringes, vials

Additional equipment such as CT scanners, Instron tensile test machines and SEM may be used.

Knowledge of pharmaceutical/biotech processes

Familiarity with validation processes for Packaging areas

Familiarity with serialization process and networking

Familiarity with documentation in a highly regulated environment

Ability to operate specialized equipment, tools and computers as appropriate.

Ability to interpret and apply GAMPs and GMPs and familiarity with documentation in a highly regulated

Lead evaluation of returned products, product reserve sample inspections, batch records and review of complaint histories and trends

Engineers are involved in every stage of the medical device development process, from concept design and prototyping to testing, manufacturing, and commercialization

Provide input to engineering for product improvements

Partner with device engineering to develop structured failure analysis processes and tools for current and future device platforms

Generate final reports in accordance with established procedures, which may include data collection and statistical analysis of the data

Help with investigations lab equipment setup, develop and provide equipment training to personnel, develop and validate test methods, and develop SOPs for equipment use.

Preferred Qualification:

Bachelor’s degree in science OR master’s degree in science

2-3 years of experience in development or manufacturing environment, working with Medical Devices, ideally Class II and Class III

Demonstrated Six Sigma proficiency specifically for root cause analysis methodology

Experience with risk management per ISO 14971 (System Risk Analysis, User Risk Analysis, DFMEA/FMEA and other Risk Management tools)

Strong technical writing and interpersonal skills

Pay Transparency: The typical base pay for this role across the U.S. is: $35.00 - $42.00/hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.

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