Overview

We are looking to add a Senior Manufacturing Engineer with a focus on the NPI side. This role will be responsible for managing Process Transitions through Validation to Manufacturing control. This individual will be responsible and manage Process Improvement/Optimization and Process Development projects utilizing design for manufacturing and Lean Six Sigma methodologies. The ideal candidate will have strong skills in working with our R&D team and Production (Sustaining) teams to help get new products moved into production. This role will work closely with project managers, sales personnel and/or directly with customers to evaluate and develop new or existing opportunities. This may include developing simple automation projects (including vision, fixtures, basic programming, etc), resulting in customer development samples to high volume commercial product.

Join Resonetics and be part of a team that’s redefining medical device manufacturing. If you’re passionate about innovation and thrive in a fast-paced environment, we’d love to hear from you.

Responsibilities

• Work closely with project managers, sales personnel and/or directly with customers to evaluate and develop new or existing opportunities.
• Process Transitions Manufacturing
  • Management of Handoff
  • Process Validation / Equipment Qualification
  • Accept Process Ownership from Applications / Systems Engineering
• Process Improvement / Optimization
  • 5S
  • One Piece Flow
  • Kaizen
  • Line Layout / Cell Manufacturing
• Coordinate closely with Development and Manufacturing Engineering to define and document component manufacturing requirements and processes as devices move through the development lifecycle.
• Work with cross-functional departments to confirm manufacturing line readiness and ensure appropriate equipment, space and staff are prepared.
• Finalize inspection procedures including defining inspection sample size and inspection techniques/gages for each lot of parts.
• Write work instructions and train production staff on procedures.
• Draft process risk assessment (PFMEA), process flow charts, and control plans.
• Perform process validation (IQ/OQ/PQ/MVP/TMV) and gage R&R activities, as required.
• Ensure bill of materials and job router accuracy.
• Solidify tooling documentation for production release using SolidWorks, including tool design updates for manufacturability and tool drawing creation/modification.
• Review process metrics to identify areas of improvement during the transfer process.
• Ensure that accurate and complete QMS/DMR records are generated through the change order process, including documentation of both finished components and raw materials.
• Monitor transfers post-release for lessons learned or process improvements.
• Provide constructive feedback to the production transfer process, and participate in continuous improvement initiatives such as creating templates for similar processes.
• Assist in driving manufacturing engineering projects to completion, including making sure the work is done satisfactorily and timely.
• Other duties as assigned.

Required Qualifications

• 5-10+ years of Manufacturing/Process Engineering experience or equivalent.
• BS degree in Engineering or Physics.
• Experience with Process/Product Transitions through Validation to Manufacturing.
• Demonstrated Project Management experience dealing with interdisciplinary interaction to meet project schedules
• Experience with project costing/budgeting
• General understanding of statistical analysis for purposes of equipment validation.
• Experienced with Process Improvement/Optimization utilizing Lean Six Sigma (LSS) skillset.
• Strong organizational skills.
• Excellent communication skills.
• Strongly motivated and goal oriented.
• Will adjust working hours and/or work extra hours to meet project deadlines.

Preferred Qualifications

• Tooling Design
• Experience with Laser processes and optics
• Experience with precision motion / vision systems
• Project Management Professional (PMP)
• LSS Black Belt
• ISO 13485:2003, ISO 9001:2008

Compensation

The compensation for this role is competitive and will be based on experience and qualifications. The anticipated range is $78,000-$124,000.

For temp, temp-to-hire, and regular full-time positions, 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.