Engineer III

SGS_JOB_2264

Engineering
 Pennsylvania
Compliance with GMP
OSHA
EPA
FDA
ISO Standards
Management of Change (MOC) Process
Design Verification & Validation (DHF
GMP
FDA
ISO
CE)
Tooling & Automation Design (Semi/Automated Equipment)
Product & Process Development
Manufacturing Process Improvements (Melt Processing
Chemical
Machining
Mechanical)

Contract - 12 Months (possible extension)

Location (mandatory): Exton, PA 19341 (Onsite) Experienced in product and process development from prototype to full-scale manufacturing, with expertise in optimizing performance variables, scaling up processes, and implementing improvements in productivity, efficiency, and reliability. Skilled in designing novel tooling and automation solutions, supporting regulatory and quality compliance (GMP, FDA, ISO, CE), and leading cross-functional project teams across R&D, Operations, Quality, and Regulatory. Strong background in root cause analysis, continuous improvement, machine safety assessments, and design verification/validation, while also contributing to grant, patent, and regulatory filings. Proven ability to bridge research with commercialization by driving innovation, ensuring compliance, and supporting daily manufacturing operations.

Job Responsibilities:

  • Identifying and optimizing product/process variables required for maximizing product/process performance at prototype, lab/pilot, and full production scale
  • Leading evaluation of final product specifications by prototyping products/processes and performing experiments; from lab to production scale
  • Developing novel processes/tooling concepts for new process development, and evaluate concepts based upon manufacturing key performance indicators (KPIs)
  • Proving product/process performance at prototype, lab/pilot scale, and full production scale
  • Leading evaluation of scale up options, selection, & implementation by leading sub projects, providing project updates, and offering input for the next phases
  • Evaluate, identify and recommend/implement improvements (productivity, efficiency, reliability) to existing processes (melt processing, chemical, machining or mechanical) or products.
  • Support research efforts related to identifying and/or evaluating new technologies, biomaterials and/or medical implants.
  • Support Operations to address plant layout, resources, and start up milestones
  • Developing all necessary documentation to support new/or improved process scale up to manufacturing verification
  • Design, assemble and test semi-automated and automated tooling required to improve current processes, or needed for new projects/product lines
  • Create and/or process ECN’s, process routers, drawings, and other written documentation in accordance with GMP requirements to support product development, process development, validations and manufacturing.
  • Leading evaluation of potential new product/process proposals and provide recommendations as to the scope and necessary timing required for specific production targets
  • Developing project plans, estimating project costs, operating costs, project schedules milestones, and resource requirements.
  • Support customer quotations for new/changes to products/processes
  • Leading improvement of infrastructure and capabilities
  • Analyzing results of experiments against objectives/targets
  • Working with supervisors and other associates to ensure execution of experiments in a timely manner
  • Leading Machine design verifications reviews.
  • Support Design Verifications, Design & Development reviews, and Verifications & Validations for new product development.
  • Providing in-house development and/or technical support to Operations
  • Conducting investigations and implementation of improvements into manufacturing product/processing issues
  • Support Operations in the daily manufacturing of commercial products.
  • Conducting investigation into customer complaints and resolution as it relates to manufacturing process, equipment or product requirements
  • Providing in-house development and/or technical leadership to Operations
  • Leading continuous improvement on projects/processes to achieve improvements in productivity, yield and/or operating costs
  • Leading investigation and performing root cause analysis into customer complaints
  • Support preparation of applicable technical sections for grants, patent, & regulatory filings
  • Leading Management of Change (MOC) review process
  • Participating in HAZOP and PSA teams as needed
  • Leading Machinery Safety Assessment (MSA)
  • Following DSM Life Saving Rules (LSR), encourage fellow colleagues to work to the same standards.
  • Following Design Control and Risk Management procedures
  • Participate in auditing medical device design history files
  • Assist in the preparation of applicable technical sections of regulatory documents (FDA 510k, IDE, PMA, CE), grants, & patent filings.
  • Keep up to date on industrial and academic technological developments and exploring opportunities to incorporate them into process development/commercialization process
  • Directing or participating in project teams within the PMP/Project Management process
  • Execute the job within the applicable DSM, GMP, OSHA, EPA, ISO, FDA, CE, & other requirements.
  • Directing or participating in a variety of projects with cross-functional project teams. Collaborating with Strategic Business Innovation, Strategic Business Management, Research & Development, Quality, Regulatory, Safety, Finance, & Manufacturing groups.
  • Participating in Engineering Change Notice (ECN) Board

Skills:

  • 7+ years of hands-on experience in a fast-paced manufacturing environment, preferably in medical equipment or devices.
  • Demonstrated experience designing, building, and maintaining small tools and fixtures using Creo or related software packages.
  • Experience generating ideas, getting business support, and then driving the idea to an implemented solution.

Education/Experience:

  • Bachelor of Science degree in Mechanical, Chemical, or Industrial Engineering.
  • Other engineering-related degrees will be considered with relevant experience.

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