Be an early applicantLess than 25 applicants

Company

Original Job Post

Medtronic · 2 days ago

Process Development Engineer II - Extrusion

Beverly, MA

Full-time

Onsite

Entry, Mid Level

2+ years exp

Wonder how qualified you are to the job?

Maximize your interview chances

BiotechnologyHealth Care

H1B Sponsorship

Actively Hiring

Insider Connection @Medtronic

Discover valuable connections within the company who might provide insights and potential referrals, giving your job application an inside edge.

Responsibilities

Develop new extrusion process to meet delivery catheter system requirements.

Provide technical and sustaining engineering support in a manufacturing area.

Recommend and implement equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques as well as production yields for existing products.

Integrate equipment and material capabilities to meet process module target specifications and technology target specifications.

Review product development requirements for compatibility with processing methods to determine costs and schedules.

Interact with product design and development personnel to ensure that processes and designs are compatible.

May develop and conduct statistical analysis or recommend additions to document work.

Lead the innovation, development and/or optimization of new manufacturing concepts, processes and procedures for transfer to manufacturing operations; This can include scouting and feasibility work, material selection, process and equipment selection, tooling / fixture and equipment installation and assessment of inputs, outputs and alignment to requirements.

Develop manufacturing processes that are applicable to statistical process control and may develop those techniques including the measurement systems.

Ensure processes and procedures are compliant with regulations.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

ExtrusionProcess DevelopmentMulti-Lumen ExtrusionVacuum FormingShrink TubingBraided CatheterExtruded CoatingMultilayer Co-ExtrusionBump TubingProcess ValidationsStatisticsSPCMinitab SoftwareDesign ControlsFDA RegulationISO 1348521 CFR 820CGMP PracticesGD&TValidation ProtocolsIQPDPCOQPQTMV

Required

Bachelors degree required

Minimum of 2 years of relevant experience, or advanced degree with 0 years of experience

Extrusion Experience

Preferred hands-on-experience in extrusion process development with 2-5 years of experience

Extrusion experience in developing any one or more of the following process is preferred.

Multi-lumen extrusion

Vacuum forming extrusion

Shrink tubing

Intermittent / full A/B extrusion

Braided catheter extrusion

Extruded Coating

Multilayer co-extrusion

Bump tubing

Experience in process validations, statistics and SPC using Minitab software

Familiar with design controls, FDA regulation - ISO 13485, 21 CFR 820, and CGMP practices

Good working knowledge of GD&T

Generate and conduct validations independently and assist technicians and engineers in executing validation protocols (IQ/PD/PC/OQ/PQ/TMV)

Preferred

Extrusion Experience

Preferred hands-on-experience in extrusion process development with 2-5 years of experience

Extrusion experience in developing any one or more of the following process is preferred.

Multi-lumen extrusion

Vacuum forming extrusion

Shrink tubing

Intermittent / full A/B extrusion

Braided catheter extrusion

Extruded Coating

Multilayer co-extrusion

Bump tubing

Experience in process validations, statistics and SPC using Minitab software

Familiar with design controls, FDA regulation - ISO 13485, 21 CFR 820, and CGMP practices

Good working knowledge of GD&T

Generate and conduct validations independently and assist technicians and engineers in executing validation protocols (IQ/PD/PC/OQ/PQ/TMV)

Benefits

Short-term incentive plan

Medtronic Incentive Plan (MIP)

Wide range of benefits

Resources

Competitive compensation plans

Company

Medtronic

Glassdoor

3.9

Medtronic develops healthcare technology solutions for various medical conditions.

Founded in 1949

Minneapolis, Minnesota, USA

10,001+ employees

https://www.medtronic.com

H1B Sponsorship

Medtronic has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Trends of Total Sponsorships

2023 (185)

2022 (337)

2021 (383)

2020 (274)