Principal Process Development Engineer - IPG

LCI-Lawinger Consulting; Fridley (MN); On-site; USD 135,000 - 185,000; Full time

Benefits offered by this job

Health & welfare options

Company-paid life & AD&D

Long-term disability

Flexible time off

Paid parental leave

Paid holidays

Job summary

LCI-Lawinger Consulting in Fridley, Minnesota seeks a Principal NPI/Process Development Engineer to lead the development, improvements and implementation of cost-efficient manufacturing processes for active implantable devices.

You will mentor engineers, coordinate R&D-to-manufacturing transfers, drive LEAN initiatives and ensure compliance with quality systems and validation activities.

Qualifications

• Bachelor’s degree in engineering or related field.
• 10+ years in medical device industry focusing on Active Implantable Devices.
• Experience with validations for laser welding, header attachment, moisture, and helium leak testing.
• Experience with design for manufacturing, design control and quality systems.
• SolidWorks and Mastercam experience.

Responsibilities

• Lead development and implementation of cost-effective manufacturing processes.
• Coordinate transfers from R&D to manufacturing.
• Mentor engineers and technicians.
• Write ECOs and change orders to manufacturing documents.
• Support multiple departments to ensure compliance with requirements.
• Propose and implement LEAN manufacturing initiatives.

Skills

People skills

Leadership

Project management

Education

Bachelor’s degree in engineering or related field

Tools

SolidWorks

Mastercam

MS Office

Job description

Job Summary

The Principal NPI/Process Development Engineer position leads the development, improvements and implementation of optimal cost-effective designs and associated processes that meet the high rigor of product requirements and exceptional quality standards. This role will work specifically with active implantable products.

Essential Functions

• Works independently to drive project completion by developing the processes used to manufacture component, sub-assemblies, and FG devices.
• Provides leadership and mentors less experienced engineers and technicians.
• Acts as the liaison between development and operations.
• 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.
• Prepares 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.

Requirements

Education, Experience, Required Skills

• Bachelor’s degree in engineering or related field
• 10+ years related experience in medical device industry with a heavy focus on product or process development of Active Implantable Devices. Strongly preferred experience in Neuromodulation Devices (IPGs or Leads). Experience with pacemakers, cardiac monitors, brain computer interface, etc. also considered.
• Extensive experience with process validations for laser welding, header attachment, and internal moisture (bake) and Test Method Validation for Helium Leak Testing.
• 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 Requirements

• 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.

Summary of Benefits

• Group health & welfare benefits: Options for Medical, Dental and Vision insurance, Health Savings Account (requires participation in eligible medical plan), and Flexible Spending Accounts.
• Company-paid benefits: Employee Life Insurance & Accidental Death & Dismemberment (AD&D), Long Term Disability (LTD), Kavira (requires participation in medical plan).
• Voluntary, employee-paid benefits: Employee Supplemental Life & AD&D, Spouse and Dependent Life & AD&D, Short Term Disability (STD), Accident, Critical Illness, and Hospital Indemnity, Employee Assistance Program.
• Flexible Time Off Program
• Paid Parental Leave
• Paid Holidays
• Benefits and incentive compensation may be subject to generally applicable eligibility, waiting period, contribution, and other requirements and conditions.

Compensation

• The typical base pay range for this role is between $135,000-185,000/year. Compensation may vary based on individual job-related knowledge, skills, expertise, and experience. This position is eligible for a discretionary annual incentive program driven by organization and individual performance.