Resolution Medical · 2 months ago
Sr. Process Development Engineer - Delivery Systems
Minneapolis, MN
Full-time
Onsite
Senior Level
$105K/yr - $120K/yr
5+ years expResolution Medical is a company focused on developing complex catheter-based delivery systems. The Senior Process Development Engineer will refine manufacturing processes and serve as a technical expert, ensuring robust production for high-performance medical devices through collaboration with cross-functional teams.
Health CareMedical Device
Responsibilities
Works independently to develop, optimize, and validate manufacturing processes for catheter-based delivery systems including reflow, bonding, molding, of reinforced shaft assembly processes used to manufacture components, sub-assemblies, and finished devices
Provides leadership and trains less experienced engineers and technicians when needed, while remining primarily an individual contributor for driving process execution within project teams
Acts as the liaison between Product Development and Operations, ensuring smooth transition of designs into stable, validated manufacturing processes that meet performance and quality targets
Advocates for robust, repeatable processes that consistently produce catheters meeting design requirements and regulatory standards. Leads DOE studies and data analysis using tools such as Minitab
Prepares and presents detailed process development and validation plans, defining scope, resources, and timelines to complete assigned projects
Develops schedule milestones, coordinates manpower, 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 and develops custom tooling and fixtures to support cleanroom manufacturing and process efficiency and reducing complexity of operator skill. Engineer should utilize best practice and make vs. buy assessment to determine if off the shelf available machinery is best to implement on product lines while considering recommended manufacturing methods while providing ROI analysis
Performs product/process analysis for capability (Cpk/Ppk), yield, and efficiency improvement using statistical and risk-based approaches. Supports manufacturing readiness reviews and gate reviews, and process validation (OQ/PQ/PPQ) activities
Writes and implements engineering change orders related to manufacturing documentation, tooling, and process updates, ensuring control and regulatory compliance
Support company finance, accounting, human resources, quality, regulatory, and clinical departments as necessary to ensure compliance with requirements
Performs other related duties as assigned by management
Qualification
Required
Bachelor's degree in related field (equivalent work experience may be considered)
5+ years of related experience as an individual contributor, with strong strategic focus in the areas of Product and Process development
Strongly preferred hands-on experience in catheters, balloons, steerable sheaths, braiding, coiling, handles, molding, and general delivery systems
Demonstrated ability to independently develop medical device manufacturing processes from concept to production
Experience with medical device Design for Manufacturability (DFM), design control, process validations (IQ/OQ/PQ), medical device 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
Proficiency with programs including SolidWorks and/or Mastercam
MS Office Proficiency
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.
401(k) Plan: Company-provided Safe Harbor Contribution of 3% of eligible earnings.
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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