Senior Process Engineer

Job Summary

Responsible for leading and executing the development, sustainment, and validation of processes and equipment used in the manufacture of medical device product(s) including determination of process flow, fixture/tooling development, and generation of engineering and production documentation, including work instructions and process FMEAs for both internal and supplier‑based processes. Also responsible for supporting cross‑functional projects related to existing and new products, as necessary, including recommended changes to specifications based on manufacturing process input.

Will use a wide degree of creativity and latitude to accomplish varied and complicated tasks relying on experience and judgement to plan and accomplish goals.

• Work with production facilities and vendors to develop, evaluate, document, implement and improve manufacturing processes throughout the product life cycle, including process control techniques, related fixtures and tooling, training personnel when required, and estimation of staffing requirements, production times, and relative costs to provide data for production decisions
• Develop and maintain plans and timelines related to project tasks throughout the process development cycle, taking into account resource constraints
• Act as a technical liaison between the cross‑functional team and the production facilities, including vendors, for new and existing products and processes
• Lead process‑related risk management activities including process FMEAs, as well as support application and design FMEAs related to products
• Plan, create, and execute validations (IQ/OQ/PQ) in accordance with FDA and ISO harmonized standards including preparation of technical protocols, reports and feasibility studies
• Plan, lead, and facilitate production transfers, including production floor layout and facility planning activities (equipment spacing, utilities, etc.)
• Comply with all SOP and regulatory requirements pertaining to the development of medical device (per FDA 21 CFR part 820 and ISO 13485)
• Develop appropriate preventative maintenance plans, and coordinate calibration and preventative maintenance activities with Quality and Production departments
• Interface with quality and development engineers concerning critical aspects for inspection procedures and gauges on new and existing products
• Create and maintain accurate documentation of process specifications, work instructions, tooling drawings, design concepts, shop orders, and concepts in accordance with the R&D and quality assurance functions
• Provide engineering support for production facilities, including vendors, to trouble‑shoot and resolve technical problems
• Optimize product, processes, tooling and/or equipment that meet customer needs, technical design goals, regulatory/quality requirements, and cost/efficiency goals through use of Lean/Six Sigma techniques and tools
• Attend and contribute to team meetings in conjunction with assigned projects
• Evaluate new processing technologies

• B.S. in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, Packaging Science, or other appropriate engineering discipline
• More than 10 years of relevant experience in the medical device and/or pharmaceutical field, with a demonstrated understanding of industry requirements and regulations
• Computer literate & experienced in Microsoft Office applications, D365 experience preferred
• Experience with process mapping, development, characterization, qualification/validation and capability analysis preferred
• Experience in 3D modeling and drafting;
  Solid Works software experience preferred
• Must fit within the Safeguard Medical culture

• Self‑directed, demonstrating ownership and accountability
• Demonstrates the ability to plan, execute, control and deliver on project tasks and overall goals
• Strong written and verbal communication skills
• Team‑oriented personality with the ability to influence others effectively while contributing to and maintaining a positive environment
• Enthusiastic, cooperative, and positive work behaviors essential for a collaborative work environment, including building lasting…