Sr. Process Development Technician - Delivery Systems

Resonetics; Fridley (MN); On-site; USD 44,000 - 58,000; Full time

Job summary

Resonetics in Minnesota is seeking a Development/Pre-Production Manufacturing Engineer to execute development builds, support transfer to Operations, and drive process improvements in catheter and delivery system assembly within a cleanroom environment.

The role requires 5+ years in product or process development, experience in catheter assembly, and strong problem-solving, documentation, and training abilities. Travel minimal; fast-paced, collaborative culture.

Qualifications

• 2-year degree in related field preferred; equivalent experience may be considered.
• 5+ years in product or process development as an individual contributor.
• Direct experience with catheter and delivery system assembly preferred.
• Experience launching devices from Development to Operations.

Responsibilities

• Builds product through all phases of Product Development in cleanroom and manufacturing.
• Oversee catheter and delivery system operations (braiding, coiling, reflow, welding, extrusion, balloon bonding, tipping, skiving).
• Design fixturing and procure equipment; install and maintain equipment.
• Draft and optimize manufacturing procedures; document changes.
• Identify and implement process improvements and qualify equipment.
• Train operators to perform manufacturing procedures.
• Manage development builds and associated build records; support tech transfer.
• Prototype with understanding of manufacturing processes; work with limited supervision.

Skills

Product development

Process development

Training & mentoring

Problem solving

Documentation

Quality focus

Communication

Supervision-free work

Education

Two-year degree

Equivalent work experience

Tools

Laser spot welding

Laser seam welding

Measurement equipment

Job description

Overview

Resonetics is a global leader in advanced engineering, prototyping, product development, and micro manufacturing, driving innovation in the medical device industry. With rapid expansion across all our locations, we continue to push the boundaries of technology while fostering a dynamic, employee-centered culture. Our commitment to excellence and continuous improvement makes Resonetics an exciting place for professionals passionate about shaping the future of micro-manufacturing and being part of something bigger.

This position will primarily focus on executing development and pre-Production builds, identifying and implementing process improvements, training operators to perform manufacturing procedures, and transferring medical devices from Development to Operations.

Join Resonetics and be part of a team that’s redefining medical device manufacturing. If you’re passionate about innovation and thrive in a fast-paced environment, we’d love to hear from you.

Responsibilities

• Builds product through all phases of Product Development in both a cleanroom and general manufacturing environment
• Oversee complex catheter and delivery system operations such as: Braiding, coiling, reflow, welding, extrusion, balloon bonding, tipping, skiving, and performance testing
• Assists in the design of fixturing and procurement of equipment
• Installs and maintains equipment / fixturing
• Utilizes manual and/or automated measurement equipment/tools
• Accurately drafts and optimizes manufacturing procedures
• Assists in identifying and implementing process improvements including equipment qualifications and releasing documentation (document change records)
• Proficient at solving problems in a timely manner
• Understands cause and effect as it pertains to process development
• Works with a positive attitude and acts within the corporate guiding principles
• Teaches and trains others on performing manufacturing procedures
• Manages and executes development builds and associated build records
• Highly skilled in prototyping and understanding manufacturing processes
• Ability to work with limited supervision

Required Qualifications

• 2-year degree in related field strongly preferred (equivalent work experience may be considered)
• 5+ years of experience as an individual contributor with a strong focus in Product or Process Development
• Direct experience with complex catheter and delivery system assembly strongly preferred
• Demonstrated ability to successfully launch devices from Development to Operations
• Strong background in assembly, experience working in a cleanroom environment and knowledge of medical component or device manufacturing is preferred
• Experience with laser spot and seam welding processes and equipment
• Knowledge with Fine/Gross leak methods and testing a plus
• UVCA/Epoxy molding/casting processes and tooling design preferred
• Working understanding of ESD safe processes and best practices
• Solid technical ability with demonstrated attention to detail
• Focus on quality
• Excellent written and verbal communication skills
• Ability to work well with teams
• Ability to handle and be trusted with confidential and/or sensitive information.
• Able to work in a fast-paced, constantly changing environment.
• Ability to be flexible and to handle multiple projects in an organized, timely manner.
• Able to problem-solve, work under pressure, and to effectively manage stress.

Physical Demands

• Prolonged periods of sitting at a desk and working on a computer and/or microscope
• Prolonged periods of standing and/or walking
• Must be able to lift up to 25 pounds at times
• Manual dexterity in order to assemble products or machines as directed
• Excellent hand-eye coordination
• Ability to differentiate between colored wires, tabs, and electronic components
• Must wear gown, gloves, and ear protection when applicable
• Must be willing to work in lab and clean room environments to support project work

Compensation

• The compensation for this role is competitive and will be based on experience and qualifications. The anticipated range is $32.00–$42.00/hr.
• Our company policy is that we are unable to provide visa sponsorship. Candidates must already be legally authorized to work in the United States without the need for sponsorship now or in the future.