Senior Process Development Engineer

medical device client in Maple Grove is looking to add Process Development Engineering talent to their team. This Senior/Principal Process Development Engineer will work cross-functionally to lead process development of complex technologies and ensures effective transfer of product into production. We are looking for someone onsite, 5 days a week from a medical device manufacturing background!

• Analyzes design specifications and translate the requirements into robust manufacturing procedures to achieve quality and reliability of finished products.
• Assesses process capabilities, prioritizes process improvement opportunities, and implements process improvements on existing manufacturing processes.
• Applies technical knowledge to innovate, design, and develop processes, tooling, and equipment.
• Defines and releases the deliverables as defined by individual design and development plans.
• Defines and releases Process Failure Modes and Effects (PFMEA) analysis, and Master Validation Plans (MVP)
• Defines and releases 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 (destructive/nondestructive) data, means/variance testing) to evaluate process capability, validate measurement methods, and drive data-based decision-making for product and process improvements
• Provides design for manufacturing (DFM) input to the assembly and component specifications.
• Compiles and writes training materials; develops and conducts training sessions.
• Works collaboratively with appropriate departments/teams to develop product design and tooling processes to ensure efficient production methods.
• Interfaces with outside vendors to determine product specifications; coordinates purchase of equipment, materials, and/or parts; evaluates products to ensure they meet specifications and quality standards.
• Estimates production times, staffing requirements, and related costs to provide information for management decisions.
• Estimates future manufacturing requirements and potential.
• Analyzes data for process investigations, productivity improvements, cost analysis, regulatory filings; documents and communicates results.
• Performs other related duties as assigned by management.

• 5-10 years of process development/ process improvement experience
• BS in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering
• Demonstrated ability to work cross-functionally in a 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
• Working knowledge of data collection, data analysis, evaluation, and scientific method

Salary of $100,000 - $150,000 + 10/15% bonus, depending on experience level