Senior Process Development Engineer - Medical Devices

Resonetics; Fridley (MN); On-site; USD 118,000 - 186,000; Full time

Job summary

Resonetics in Minnesota is seeking a Principal Process Development Engineer to lead development and optimization of manufacturing processes for medical devices. You will drive cross-functional projects, coach engineers, and ensure processes are repeatable, compliant, and cost-effective from concept to production.

You'll collaborate with operations, quality, and regulatory teams, design, evaluate equipment, write change orders, and support capital expenditures.

Qualifications

• Bachelor’s degree in engineering or related field.
• 10+ years related experience in medical device industry with a focus in Process Development.
• Demonstrated ability to independently develop medical device manufacturing processes from concept to production.
• Experience with medical device Design For Manufacturing, design control, quality systems and product development phases.
• Demonstrated ability to implement change in a way that positively impacts overall department and company performance.
• Must be able to handle multiple projects simultaneously.
• Must excel at working in a team environment with a high level of people/interpersonal skills and demonstrated ability to cross functionally drive results.
• Experience using influence to affect project and organizational success.

Responsibilities

• Works independently to drive project completion by developing the processes used to manufacture component, sub-assemblies, and FG devices.
• Provides leadership and coaches less experienced engineers and technicians.
• Acts as the liaison between development and operations.
• Coaches less experienced engineers and technicians.
• Advocates for the process to ensure they arerepeatableand can capably produce product that meets the design requirements.
• Prepares and presentsdetailed plans necessary to complete assigned projects.
• Develops schedule milestones, coordinates resources, facility and equipment for assigned projects.
• Assists in improving the system of production controls, standard operating procedures, safety, quality control and training.
• Prepares and maintains detailed layouts of buildings and equipment.
• Coordinates the manufacturing launch of new/revised products including establishing goals, training team members, and evaluating results.
• Designs, develops and tests as well as sources various tools, machinery and equipment for recommended manufacturing methods while providing ROI analysis.
• Performs product/process analysis for production and quality metrics.
• Write engineering change orders to process changes to manufacturing documents, drawing, and Bill of Materials
• Support company finance, accounting, human resources, quality, regulatory, and clinical departments as necessary to ensure compliance with requirements
• Recommend, support and implement improvements, modifications, or additions that will improve work processes
• Take the lead in analyzing the need for new process development and to meet company needs including specifying, ordering, installing and validating new equipment or processes
• Prepare justification for capital expenditures
• Aid in production transfers from R&D to manufacturing
• Propose potential new manufacturing technologies, including automation and new equipment
• Contribute to the definition, development and implementation of LEAN manufacturing initiatives

Skills

Process development

Leadership

Team collaboration

Quality systems

Education

Bachelor’s degree in engineering or related field

Tools

SolidWorks

Mastercam

MS Office

Job description

Resonetics in Minnesota is seeking a Principal Process Development Engineer to lead development and optimization of manufacturing processes for medical devices. You will drive cross-functional projects, coach engineers, and ensure processes are repeatable, compliant, and cost-effective from concept to production.

You'll collaborate with operations, quality, and regulatory teams, design, evaluate equipment, write change orders, and support capital expenditures.