Sr. Process Development Engineer - Delivery Systems

RESOLUTION MEDICAL LLC • Minneapolis, MN

68d • $105,000 - $120,000

About The Position

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. The engineer will serve 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.

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.

Responsibilities

• 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.
• Provide leadership and train less experienced engineers and technicians when needed, while remaining primarily an individual contributor for driving process execution within project teams.
• Act as the liaison between Product Development and Operations, ensuring smooth transition of designs into stable, validated manufacturing processes that meet performance and quality targets.
• Advocate for robust, repeatable processes that consistently produce catheters meeting design requirements and regulatory standards.
• Lead DOE studies and data analysis using tools such as Minitab.
• Prepare and present detailed process development and validation plans, defining scope, resources, and timelines to complete assigned projects.
• Develop schedule milestones, coordinate manpower, facility and equipment for assigned projects.
• Assist in improving the system of production controls, standard operating procedures, safety, quality control, and training.
• Prepare and maintain detailed layouts of buildings and equipment.
• Coordinate the manufacturing launch of new/revised products including establishing goals, training team members, and evaluating results.
• Design and develop custom tooling and fixtures to support cleanroom manufacturing and process efficiency and reducing complexity of operator skill.
• Perform product/process analysis for capability (Cpk/Ppk), yield, and efficiency improvement using statistical and risk-based approaches.
• Support manufacturing readiness reviews and gate reviews, and process validation (OQ/PQ/PPQ) activities.
• Write and implement 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.
• Perform other related duties as assigned by management.

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.
• 401(k) Plan: Company-provided Safe Harbor Contribution of 3% of eligible earnings.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Bachelor's degree