Senior Process Development Engineer

About the role

This role offers the opportunity to lead process development efforts for innovative products, from early-stage development through manufacturing launch. You'll work cross-functionally to develop, validate, and improve manufacturing processes while providing technical leadership, analyzing data, and driving successful product commercialization. The ideal candidate enjoys hands-on problem solving, collaboration, and continuous improvement.

Responsibilities

• Lead the development, optimization, and validation of manufacturing processes for highly regulated products.
• Drive technical problem-solving efforts and provide solutions to complex engineering and manufacturing challenges.
• Apply process characterization methodologies and statistical tools, including DOE, risk assessments, and data analysis, to support decision-making.
• Develop, implement, and maintain robust manufacturing processes to support new product introductions and product scale-up activities.
• Identify, evaluate, and implement new equipment, tooling, and fixtures, including qualification and validation activities.
• Author and review technical documentation, validation protocols, engineering studies, and process development reports.
• Collaborate with cross-functional teams to ensure successful project execution and transfer into production.
• Provide technical guidance and mentorship to engineers and support a culture of continuous improvement.
• Partner with manufacturing teams to troubleshoot production issues and improve process performance.
• Support strategic initiatives and additional engineering projects as needed.

Requirements

• Bachelor's degree in Engineering or a related technical discipline preferred.
• 5+ years of engineering experience in process development, manufacturing engineering, or a related field.
• Experience in regulated manufacturing environments strongly preferred, with medical device experience being a plus.
• Hands-on experience with process validation, equipment qualification, and manufacturing process development.
• Strong understanding of statistical analysis and data-driven decision-making methodologies.
• Proven ability to manage technical projects, prioritize workstreams, and drive results.
• Excellent communication skills, with the ability to present technical concepts to diverse audiences.
• Demonstrated success working cross-functionally and influencing stakeholders at multiple levels of an organization.
• Experience supporting continuous improvement initiatives and implementing process enhancements.
• Willingness to travel between local manufacturing and engineering sites as business needs require.

Benefits

In addition to base pay, direct-hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law.