Sr. Process Development Engineer - Delivery Systems

Sr. Process Development Engineer - Delivery Systems

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This role focuses on post–design-freeze activities such as tooling, fixture development, process characterization, and validation (IQ/OQ/PQ) to ensure robust and scalable production for high-performance medical devices. The engineer serves as a technical subject matter expert on customer and internal project teams, driving process innovation and execution through collaboration with Quality, Operations, and Program Management.

• 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 remaining 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; conducts make vs. buy assessments and ROI analyses for equipment selection.
• 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 (IQ/OQ/PQ/PPQ) activities.
• Writes and implements engineering change orders related to manufacturing documentation, tooling, and process updates, ensuring control and regulatory compliance.
• Supports company departments (finance, accounting, HR, quality, regulatory, and clinical) to ensure requirements are met.
• Performs other related duties as assigned by management.

• 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 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
• Ability to handle multiple projects simultaneously
• Excellent teamwork and cross-functional collaboration skills
• Proficiency with Solid Works and/or Mastercam
• MS Office proficiency

• 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
• Safety gear as required (gown, gloves, ear protection, etc.)

• Group health & welfare benefits:
  Medical, Dental, Vision;
  Health Savings Account;
  Flexible Spending Accounts
• Company-paid benefits:
  Employee Life Insurance & AD&D, Long Term Disability, Kavira (with medical plan)
• Voluntary benefits:
  Supplemental Life & AD&D, Spouse/Dependent Life & AD&D, Short Term Disability, Accident, Critical Illness, Hospital Indemnity, EAP
• Flexible Time Off Program
• Paid Parental Leave
• Paid Holidays

• The typical base pay range for this role is between $-$/year. Compensation may vary based on experience. This position is eligible for a discretionary annual incentive program.
• 401(k) Plan:
  Company-provided Safe Harbor Contribution of 3% of eligible earnings.

• Seniority level:
  Mid-Senior level
• Employment type:
  
  Full-time
• Job function:
  Engineering and Information Technology
• Industries:
  Medical Device