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Sr. Process Development Engineer - Delivery Systems (Mid-Shift: 12:00 PM - 10:00 PM, Mon-Thurs)

Resolution Medical · Minneapolis, MN · 3 mo ago
On-siteEngineering$105k–$135k/yrFull-time

Job Summary

The Senior Process Development Engineer - Delivery Systems works cross-functionally to develop and refine manufacturing processes for complex catheter-based delivery systems, including reinforced catheters, balloon catheters, steerable catheters, multi-lumen, and multi-durometer shafts. This role focuses on post-design-freeze activities such as tooling, fixture development, process characterization, and validation (IQ/OQ/PQ), ensuring robust and scalable production for high-performance medical devices.

About the Role

Serves as a technical subject matter expert on customer and internal project teams, driving process innovation and execution through collaboration with cross-functional partners in Quality, Operations, and Program Management.

Essential Functions

  • Develops, optimizes, and validates 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 remaining primarily an individual contributor for driving process execution within project teams.
  • Liaises 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 Design of Experiments (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.
  • Improves the system of production controls, standard operating procedures, safety, quality control, and training.
  • Designs and develops custom tooling and fixtures to support cleanroom manufacturing and process efficiency, reducing complexity of operator skill.
  • Utilizes best practice and makes vs. buys assessments to determine if off-the-shelf machinery is best to implement on product lines while considering recommended manufacturing methods, 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.
  • Affords assistance to 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.

Requirements

  • 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

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
  • 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

Compensation

The typical base pay range for this role is between $105,000.00-135,000.00/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.

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