Secant Group · 1 day ago
Senior Product Development Engineer
Telford, PA
Full-time
Onsite
Senior Level
5+ years expSecant Group is a company focused on biomaterials for the medical device and pharmaceutical industries. The Senior Product Development Engineer is responsible for driving the development, validation, and commercialization of custom biomaterial components, collaborating with multiple teams to ensure successful project execution and compliance with quality standards.
Enterprise SoftwareInformation TechnologyMobile AppsSoftware
Hiring Manager
Denise Zavalis
Responsibilities
Lead and manage multiple projects for Research and Development in various stages of the product lifecycle in line with agreed commitments to respective clients
Collaborate with Research and Development team to gain fundamental understanding of materials and processes to effectively ready 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, polymer synthesis to develop scalable processing techniques as needed for client’s end application
Partner with cross-functional teams to facilitate projects through development cycle with ultimate transition of manufacturing process to Operations per IPDP
Design processes that are 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
Documents all project phases per IPDP and quality compliance. Compile, maintain, review and interpret product development data
Authors SOPs, Work Instructions, Batch Records, Product Specifications, Process Performance Qualification, Process Operational Qualification protocol plans and reports critical to Product development
Support Business managers with technical inputs to customers for early development programs and support Quality Assurance team with any non-conformance investigations as a subject matter expert
Qualification
Required
Bachelor's degree in Chemistry, Chemical Engineering, Biomedical Engineering, Materials Engineering, or 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 company's technical competencies to address customer's needs, and leverage companies how the needs relate to the scope of the project and how changes will affect other systems
Ability to translate client inputs into engineering requirements
Ability to explain technical concepts to internal and external project stakeholders, including process capabilities, limitations, and areas for improvement
Excellent interpersonal skills with proven ability to get work well with others in a team environment
Excellent organization and decision-making skills
Experience in technical writing and use of statistical tools, including Minitab
Proficient with MS Excel, MS Word, MS Project, and MS PowerPoint
Company
Secant Group
Secant Group, a subsidiary of Solesis, has been partnering with the medical device, pharmaceutical, and aerospace industries for 80 years through cutting-edge design, innovative development, rigorous testing, and manufacturing to develop advanced materials to make your life-changing vision a reality.
51-200 employees
H1B Sponsorship
Secant Group has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2023 (1)
Funding
Current Stage
Growth StageTotal Funding
$6MKey Investors
Primus Venture Partners
2000-08-08Series A· $6M
Company data provided by crunchbase