Resolution Medical
Sr. Process Development Engineer - Delivery Systems
Resolution Medical, Minneapolis, Minnesota, United States, 55400
Sr. Process Development Engineer - Delivery Systems
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Sr. Process Development Engineer - Delivery Systems
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Resolution Medical 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.
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 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.
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 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 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
Safety gear as required (gown, gloves, ear protection, etc.)
Summary Of Benefits
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
Compensation
The typical base pay range for this role is between $105,000.00-$120,000.00/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.
Additional Details
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Engineering and Information Technology
Industries: Medical Device
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Join to apply for the
Sr. Process Development Engineer - Delivery Systems
role at
Resolution Medical 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.
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 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.
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 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 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
Safety gear as required (gown, gloves, ear protection, etc.)
Summary Of Benefits
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
Compensation
The typical base pay range for this role is between $105,000.00-$120,000.00/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.
Additional Details
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Engineering and Information Technology
Industries: Medical Device
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