Principal Process Development Engineer

Principal Process Development Engineer

Resonetics is a global leader in advanced engineering, prototyping, product development, and micro manufacturing, driving innovation in the medical device industry. With rapid expansion across all our locations, we continue to push the boundaries of technology while fostering a dynamic, employee-centered culture. Our commitment to excellence and continuous improvement makes Resonetics an exciting place for professionals passionate about shaping the future of micro-manufacturing and being part of something bigger.

The Principal Process Development Engineer position leads the development, improvements and implementation of optimal cost-effective and compliant manufacturing processes and methods in accordance with product specifications and quality standards.

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 are repeatable and can capably produce product that meets the design requirements
• Prepares and presents detailed 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

Required 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
• Experience with programs including SolidWorks and/or Mastercam
• MS Office Proficiency
• Ability to handle and be trusted with confidential and/or sensitive information

Physical Demands

• Prolonged periods of sitting at a desk and working on a computer
• Must be able to lift up to 25 pounds at times
• Must have excellent hand-eye coordination
• Ability to differentiate between colored wires, tabs, and electronic components
• Must wear gown, gloves, and ear protection if applicable

Compensation

• The compensation for this role is competitive and will be based on experience and qualifications. The anticipated range is $118,000K-$186,000.
• Our company policy is that we are unable to provide visa sponsorship. Candidates must already be legally authorized to work in the United States without the need for sponsorship now or in the future.