Sr. Process Development Engineer - Delivery Systems

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. 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.

Essential Functions

• 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.

Education, Experience, Required Skills

• 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.
• 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.

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
• Benefits and incentive compensation may be subject to generally applicable eligibility, waiting period, contribution, and other requirements and conditions.

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.