Senior Process Development Engineer

The Senior Process Development Engineer works cross-functionally to lead process development of complex technologies and ensures effective transfer of product into production.

• Analyze design specifications and translate the requirements into robust manufacturing procedures to achieve quality and reliability of finished products.
• Assess process capabilities, prioritize process improvement opportunities, and implement process improvements on existing manufacturing processes.
• Apply technical knowledge to innovate, design, and develop processes, tooling, and equipment.
• Define and release the deliverables as defined by individual design and development plans.
• Define and release Process Failure Modes and Effects (PFMEA) analysis, and Master Validation Plans (MVP).
• Define and release process characterization, equipment installation, performance and operational qualification (IQ/PQ/OQ) protocols and reports.
• Apply advanced statistical techniques (e.g., Design of Experiments, normality assessment, measurement systems analysis for variable and attribute data, destructive/nondestructive data) to evaluate process capability, validate measurement methods, and drive data-based decision-making for product and process improvements.
• Provide design for manufacturing (DFM) input to the assembly and component specifications.
• Compile and write training materials; develop and conduct training sessions.
• Work collaboratively with appropriate departments/teams to develop product design and tooling processes to ensure efficient production methods.
• Interface with outside vendors to determine product specifications; coordinate purchase of equipment, materials, and/or parts; evaluate products to ensure they meet specifications and quality standards.
• Estimate production times, staffing requirements, and related costs to provide information for management decisions.
• Estimate future manufacturing requirements and potential.
• Analyze data for process investigations, productivity improvements, cost analysis, regulatory filings; document and communicate results.
• Performs other related duties as assigned by management.

• BS in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering (or reasonable technical equivalent) and 8+ years of process development/ improvement experience
• Demonstrated cross functional teamwork in technically demanding environment
• Demonstrated ability to develop processes from concept to production
• Highly motivated individual that can independently drive deliverables to completion through collaboration among team members.
• Demonstrated ability to develop and drive innovative solutions into processes and products.
• Understanding of DFM, medical device design control / quality systems and the product development process (PDP).
• Excellent written and oral communication skills
• Strong organizational, problem-solving, and analytical skills
• Ability to manage priorities and workflow
• Demonstrated ability to plan and organize projects
• Good judgement with the ability to make timely and sound decisions
• Creative, flexible, and innovative team player

• Working knowledge of data collection, data analysis, evaluation, and scientific method

• Employer subsidized health insurance for employees
• Employer paid dental insurance
• Employer HSA contribution
• 401k plan with a company match
• 9 paid holidays (including your birthday!) + PTO and Personal days
• Gym membership subsidy
• Employee Short Term Disability, Long Term Disability, and AD&D Life Insurance

Salary Range for This Position: $100,000 - $120,000.

Nextern is an equal opportunity employer. We encourage applications from candidates of all backgrounds and experiences, and we are committed to fostering an inclusive and diverse workplace. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.