Resolution Medical · 4 weeks ago
Principal Process Development Engineer - Catheters & Delivery Systems
Fridley,MN,US
Full-time
Onsite
Lead/Staff
$135K/yr - $185K/yr
10+ years expResolution Medical is a company specializing in medical devices, and they are seeking a Principal NPI/Process Development Engineer to lead the development and implementation of processes for complex catheters and delivery systems. This role involves driving project completion, mentoring engineers, and ensuring compliance with product requirements and quality standards.
Health CareMedical Device
Responsibilities
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
Qualification
Required
Bachelor's degree in engineering or related field
10+ years related experience in the medical device industry with a heavy focus on product and process development of catheter-based delivery systems
Strongly preferred experience in neurovascular, structural heart, or peripheral balloon and steerable catheters
Experience with braided or coiled shafts, extrusion, bonding, lamination, hydrophilic coatings, and cleanroom manufacturing
Extensive experience with process validations for catheter reflow, balloon forming, thermal bonding, and braid/coil reinforcement assembly
Experience with DOE design, process characterization, and test method validation (e.g., burst, leak, tensile, and deflection 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
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
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.
Company
Resolution Medical
Resolution Medical's Mission is to Provide Innovative Business Solutions to the Medical Device Industry.
201-500 employees
H1B Sponsorship
Resolution Medical has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (1)
2022 (1)
2021 (2)
2020 (1)
Funding
Current Stage
Growth StageTotal Funding
unknownKey Investors
BIRD Foundation
2025-10-10Grant
2021-06-02Acquired
Leadership Team
Steven Schmidt
Senior Advisor and Co-Founder of Resolution Medical
Recent News
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