Job Description

Job Title: R&D Engineer – FDA-Regulated Medical Devices

Location: Indianola, PA, 15051

Duration: 12 Months

Job Type: Contract

Work Type: Onsite

Pay rate: $25-41/Hourly/W2

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. This client is a German multinational Pharmaceutical and biotechnology company and one of the largest pharmaceutical companies in the world, headquartered in Leverkusen, and areas of business include pharmaceuticals; consumer healthcare products, agricultural chemicals, seeds and biotechnology products.

Job Description:

Position purpose

• The purpose of this contract engineering position is to support medium to large design and testing efforts pertaining to the development of new and innovative plastic sterile medical disposable products for radiology and cardiovascular devices.
• This role participates in the product design and development of new products and may support life cycle engineering of existing products.
• The individual will work as a member of a cross functional team that includes design, manufacturing, quality, regulatory, and program management in an FDA regulated environment.

Major tasks and responsibilities of position

• Lead and/or support detailed engineering design, development, and implementation of new sterile disposable product designs utilized in radiology and cardiovascular medical procedures.
• Conduct or direct testing in a Research and Development lab environment to verify concept product designs (including Samples preparation for Risk Reduction Testing, Functional Testing, etc.)
• Support verification / validation testing of production intent products using novel product designs.
• Create various design history file documentation throughout the product development process including technical assessments, test protocols / reports, and various engineering documentation.
• Writes scientific protocols, manages or performs the execution of the protocols, analyzes results, and writes reports.
• Create and modify SD designs using CAD software such as Pro Engineer and CREO. CAD models may be 3D printed as required.
• Works closely with other functions including engineering, quality, procurement, and product supply to ensure project deliverables are properly planned and aligned with broader organizational objectives.
• Other Duties as assigned.

Qualifications

• B.S in Mechanical, Biomedical, or Plastics Engineering or related field.
• 1 - 3 years of industry experience directly pertaining to mechanical / plastic engineering roles.
• Basic familiarity with medical device regulated design control process.
• Excellent problem-solving skills, creative thinker and interpersonal communication.
• Ability to perform data analysis using Minitab.

TekWissen® Group is an equal opportunity employer supporting workforce diversity.

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