Resolution Medical
Principal Process Development Engineer - IPG
Resolution Medical, Minneapolis, Minnesota, United States, 55400
Overview
Principal Process Development Engineer - IPG at Resolution Medical. The Principal NPI/Process Development Engineer leads the development, improvements and implementation of cost-effective designs and associated processes that meet high product requirements and quality standards, with a focus on active implantable products. Responsibilities
Works independently to drive project completion by developing the processes used to manufacture components, sub-assemblies, and finished goods devices. Provides leadership and mentors less experienced engineers and technicians. Acts as liaison between development and operations. Advocates for processes to ensure they are repeatable and capable of producing products that meet design requirements. Prepares and presents detailed project plans; develops schedule milestones and coordinates resources, facilities and equipment. Supports improvements to production controls, standard operating procedures, safety, quality control and training. Maintains detailed layouts of buildings and equipment. Coordinates manufacturing launches of new or revised products, including goal setting, training, and evaluating results. Designs, develops, tests and sources tools, machinery and equipment for manufacturing methods with ROI analysis. Performs product/process analysis for production and quality metrics. Writes engineering change orders affecting manufacturing documents, drawings and Bills of Materials. Supports finance, accounting, HR, quality, regulatory and clinical departments to ensure compliance. Recommends and implements improvements to work processes. Leads assessment of need for new process development and for meeting company needs (ordering, installing and validating new equipment or processes). Prepares justification for capital expenditures. Aids in production transfers from R&D to manufacturing. Proposes potential new manufacturing technologies, including automation and new equipment. Contributes to LEAN manufacturing initiatives. Requirements
Bachelor’s degree in engineering or related field 10+ years in the medical device industry with a focus on product or process development of Active Implantable Devices; strongly preferred Neuromodulation Devices (IPGs or Leads). Experience with pacemakers, cardiac monitors, brain-computer interfaces, etc. 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. Proven ability to implement changes that improve department and company performance. Ability to handle multiple projects simultaneously and to work in a collaborative, cross-functional environment. Experience influencing project and organizational success. Experience with SolidWorks and/or Mastercam; MS Office proficiency. Ability to handle confidential and 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 occasionally. Excellent hand-eye coordination; ability to differentiate colored wires, tabs, and electronic components. May require gown, gloves, and ear protection as applicable. Benefits
Group health and welfare benefits: Medical, Dental, Vision; Health Savings Account; Flexible Spending Accounts. Company-paid benefits: Life Insurance & AD&D, Long Term Disability; Kavira (participation in medical plan required). Voluntary benefits: Supplemental Life & AD&D for employee, spouse and dependents; STD, Accident, Critical Illness, Hospital Indemnity; Employee Assistance Program. Flexible Time Off; Paid Parental Leave; Paid Holidays. Benefits and incentive compensation subject to eligibility, waiting periods and plan terms. Compensation
The typical base pay range is $135,000–$185,000/year, with variation based on knowledge, skills, and experience. Eligible for discretionary annual incentive program. 401(k) Plan with Safe Harbor contribution of 3% of eligible earnings.
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Principal Process Development Engineer - IPG at Resolution Medical. The Principal NPI/Process Development Engineer leads the development, improvements and implementation of cost-effective designs and associated processes that meet high product requirements and quality standards, with a focus on active implantable products. Responsibilities
Works independently to drive project completion by developing the processes used to manufacture components, sub-assemblies, and finished goods devices. Provides leadership and mentors less experienced engineers and technicians. Acts as liaison between development and operations. Advocates for processes to ensure they are repeatable and capable of producing products that meet design requirements. Prepares and presents detailed project plans; develops schedule milestones and coordinates resources, facilities and equipment. Supports improvements to production controls, standard operating procedures, safety, quality control and training. Maintains detailed layouts of buildings and equipment. Coordinates manufacturing launches of new or revised products, including goal setting, training, and evaluating results. Designs, develops, tests and sources tools, machinery and equipment for manufacturing methods with ROI analysis. Performs product/process analysis for production and quality metrics. Writes engineering change orders affecting manufacturing documents, drawings and Bills of Materials. Supports finance, accounting, HR, quality, regulatory and clinical departments to ensure compliance. Recommends and implements improvements to work processes. Leads assessment of need for new process development and for meeting company needs (ordering, installing and validating new equipment or processes). Prepares justification for capital expenditures. Aids in production transfers from R&D to manufacturing. Proposes potential new manufacturing technologies, including automation and new equipment. Contributes to LEAN manufacturing initiatives. Requirements
Bachelor’s degree in engineering or related field 10+ years in the medical device industry with a focus on product or process development of Active Implantable Devices; strongly preferred Neuromodulation Devices (IPGs or Leads). Experience with pacemakers, cardiac monitors, brain-computer interfaces, etc. 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. Proven ability to implement changes that improve department and company performance. Ability to handle multiple projects simultaneously and to work in a collaborative, cross-functional environment. Experience influencing project and organizational success. Experience with SolidWorks and/or Mastercam; MS Office proficiency. Ability to handle confidential and 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 occasionally. Excellent hand-eye coordination; ability to differentiate colored wires, tabs, and electronic components. May require gown, gloves, and ear protection as applicable. Benefits
Group health and welfare benefits: Medical, Dental, Vision; Health Savings Account; Flexible Spending Accounts. Company-paid benefits: Life Insurance & AD&D, Long Term Disability; Kavira (participation in medical plan required). Voluntary benefits: Supplemental Life & AD&D for employee, spouse and dependents; STD, Accident, Critical Illness, Hospital Indemnity; Employee Assistance Program. Flexible Time Off; Paid Parental Leave; Paid Holidays. Benefits and incentive compensation subject to eligibility, waiting periods and plan terms. Compensation
The typical base pay range is $135,000–$185,000/year, with variation based on knowledge, skills, and experience. Eligible for discretionary annual incentive program. 401(k) Plan with Safe Harbor contribution of 3% of eligible earnings.
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