Sr. Product Development Engineer, Biomaterials

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What We Are Looking For

The Sr. Product Development Engineer, Biomaterials drives the development, validation, and commercialization of custom biomaterial components supporting the medical device and pharmaceutical industries. Responsibilities include new designs, material conversion, process optimization, process qualification, and quality compliance. The role works closely with the R&D team and regularly interfaces with business development, clients, contract manufacturers, operations, and quality engineering to deliver tasks and quality documents in accordance with the integrated product development process (IPDP).

• Lead and manage multiple projects for Research and Development at various stages of the product lifecycle, meeting commitments to respective clients.
• Collaborate with the R&D team to gain fundamental understanding of materials and processes, readying technology for transition to New Product Development.
• Partner with scientists to develop processes such as coating, formulation, mixing, dispensing, foaming, thermal processing, cross‑linking, API handling, and polymer synthesis to develop scalable processing techniques for client end applications.
• Partner with cross‑functional teams to facilitate projects through the development cycle, ensuring ultimate transition of manufacturing processes to Operations per IPDP.
• Design processes scalable to a production environment based on client inputs and volume requirements.
• Communicate manufacturing and process‑development status, expectations, and constraints to both internal and external stakeholders.
• Document all project phases per IPDP and quality compliance; compile, maintain, review, and interpret product development data.
• Author SOPs, Work Instructions, Batch Records, Product Specifications, Process Performance Qualification, and Process Operational Qualification protocol plans and critical reports for product development.
• Support business managers with technical inputs to customers for early development programs and support the Quality Assurance team with non‑conformance investigations as a subject‑matter expert.
• Perform other duties as assigned.

• Bachelor’s degree in Chemistry, Chemical Engineering, Biomedical Engineering, Materials Engineering, or a related discipline with 5+ years of relevant experience.
• Experience with Pharmaceutical Quality by Design (QbD) and/or FDA Design Controls.
• Experience managing technical projects.
• Ability to leverage the company’s technical competencies to address customer needs and to explain how changes affect other systems.
• Ability to translate client inputs into engineering requirements.
• Ability to explain technical concepts to internal and external stakeholders, including process capabilities, limitations, and improvement opportunities.
• Excellent interpersonal skills with proven ability to work effectively in a team environment.
• Excellent organizational and decision‑making skills.
• Experience in technical writing and statistical tools, including Minitab.
• Proficiency with MS Excel, MS Word, MS Project, and MS PowerPoint.

• Annual Bonuses
• Health Insurance:
  Medical with Rx plan / Dental / Vision
• 401(k) with excellent company match
• Generous Paid Time Off
• Holiday Pay
• Company‑paid Life Insurance and Disability Plans

The Secant Group is an advanced technology biomaterials company headquartered in Telford, Pennsylvania, with manufacturing facilities in Quakertown and Perkasie, Pennsylvania. Secant provides innovative solutions through next‑generation materials, structures, textile designs, and process technologies for the medical device, pharmaceutical, aerospace, and energy markets.