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TELA Bio · 2 weeks ago

Sr Product Development Engineer

Malvern, PA, US

Full-time

Hybrid

Senior Level

$80K/yr - $120K/yr

5+ years exp

TELA Bio is a company focused on surgical reconstruction products, and they are seeking a Senior Product Development Engineer. This role involves participating in the design, testing, quality control, and manufacture of products, as well as managing the transition of new products to manufacturing.

BiotechnologyLife SciencePharmaceutical

Responsibilities

Author development documentation consistent with design control requirements such as product specifications, verification/validations studies, etc

Lead the generation of risk management file and usability engineering file documentation

Design and document testing and experimental work in accordance with GxP

Coordinate with outside labs, suppliers, regulatory bodies supporting product development, product testing and process development, as needed

Conduct and/or oversee performance testing to assist research programs and development projects

Manage and conduct the translation of customer needs into product requirements and design specifications

Support regulatory submissions and technical file creation

Plan and rapidly manage/implement new product transition activities between proof-of-concept and manufacturing

Participate in early-stage development, prototyping, and test activities

Liaise with Quality and Technical Operations groups in validation and launch of new products

Qualification

Biomedical EngineeringMedical Device DevelopmentStatistical AnalysisAnalytical SkillsTechnical WritingProject ManagementAttention to DetailCreative Problem SolvingOrganizational Skills

Required

Bachelor's Degree in Engineering (e.g. Biomedical, Materials, Mechanical)

5+ years' experience in medical device product development including all phases of the product development lifecycle

Strong technical writing experience

Exposure to statistical analysis, biocompatibility testing, sterilization validation, shelf-life and packaging/ sterile barrier system validation

Demonstrated ability to multi-task and to function in a fast-paced start-up environment, manage time efficiently, achieve goals with minimal supervision and effectively interact with other employees, departments, service providers and development partners

Excellent work-ethic and attention to detail

Demonstrated ability to think creatively to identify unique solutions for product development

Strong organizational and project management skills

Strong analytical skills with demonstrated experience with organizing, managing, and presenting data to management

Ability to be self-directed given departmental goals

Ability to carry and lift product inventory of up to 20 lbs

Must have demonstrated ability to multitask in high pressure, changing conditions