Description

Job Summary

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.

Essential Functions

• 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.
  
  

Requirements

Education, Experience, Required Skills

• 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 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 $130,000-160,000/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.
• 401(k) Plan: Company-provided Safe Harbor Contribution of 3% of eligible earnings.