Manufacturing & Process EngineeringManufacturing Engineering
About the job
Requirements
A bachelor's degree in engineering or a related field.
At least 10 years of related experience in the medical device industry, with a strong focus on product or process development for active implantable devices.
Extensive experience with process validations for laser welding, header attachment, internal moisture (bake), and test method validation for helium leak testing.
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.
Ability to implement change that positively impacts department and company performance.
Ability to handle multiple projects simultaneously.
Ability to work in a team environment and cross-functionally drive results, supported by interpersonal skills.
Experience using influence to affect project and organizational success.
Experience using SolidWorks and/or Mastercam.
Proficiency in Microsoft Office.
Ability to handle confidential and sensitive information.
Ability to sit for prolonged periods and work at a computer, lift up to 25 pounds at times, demonstrate hand-eye coordination, differentiate between colored wires, tabs, and electronic components, and wear gown, gloves, and ear protection when applicable.
Responsibilities
Independently drive project completion by developing processes used to manufacture components, subassemblies, and finished-goods devices.
Provide leadership and mentorship to less experienced engineers and technicians.
Act as the liaison between development and operations.
Advocate for processes to ensure they are repeatable and can produce products that meet design requirements.
Prepare and present detailed plans to complete assigned projects.
Develop schedule milestones and coordinate resources, facilities, and equipment for assigned projects.
Assist in improving production controls, standard operating procedures, safety, quality control, and training.
Prepare and maintain detailed layouts of buildings and equipment.
Coordinate manufacturing launches of new or revised products, including establishing goals, training team members, and evaluating results.
Design, develop, and test, and source tools, machinery, and equipment for recommended manufacturing methods, and provide return-on-investment analysis.
Analyze production and quality metrics for products and processes.
Write engineering change orders for process changes to manufacturing documents, drawings, and bills of materials.
Support finance, accounting, human resources, quality, regulatory, and clinical departments as needed to ensure compliance with requirements.
Recommend, support, and implement improvements, modifications, or additions to improve work processes.
Lead analysis of the need for new process development and meet company needs, including specifying, ordering, installing, and validating new equipment or processes.
Prepare justifications for capital expenditures.
Assist with production transfers from research and development to manufacturing.
Propose new manufacturing technologies, including automation and new equipment.
Contribute to defining, developing, and implementing lean manufacturing initiatives.
Desired Qualifications
Strongly preferred experience with neuromodulation devices, including implantable pulse generators or leads; experience with pacemakers, cardiac monitors, or brain-computer interfaces is also considered.
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.