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Lifecycle Design Engineer

Company: Paragonix Technologies
Location: Cambridge
Posted on: November 26, 2022

Job Description:

Paragonix Technologies markets organ transportation devices that safeguard organs during the journey between donor and recipient patients. Our devices incorporate clinically proven and medically trusted cold preservation techniques in a novel suspension system to provide unprecedented physical and thermal protection. Our flagship product, the Paragonix SherpaPak--- Cardiac Transport System, is the only commercially available FDA cleared and CE marked transport device for heart transportation. Our product portfolio spans cardiac, thoracic, and abdominal preservation devices to improve donor organ quality and extend donor organ transport time.

Reporting to the Manufacturing and Sustaining (Lifecycle) Engineering team, this role is responsible for lifecycle design iterations of existing commercial products to support user experience, aesthetic, and functionality improvements. The successful candidate will focus efforts on implementing breakthrough improvements to our market products through creative and innovative approaches to user experience.

Primary responsibilities will include:

- The role will deploy extensive design and creative skills, coupled with a firm grasp of design for manufacturing/assembly and product quality, to make dramatic and breakthrough improvements to existing commercial products to improve user experience, device functionality, and product aesthetics.

- The successful candidate will analyze and identify design changes, build and test prototypes, and execute verification/validation studies in support of their recommendations.

- The scope of the role is all Paragonix product(s) that have gone through development and are released to commercialization.

- The role will coordinate heavily with the Product Management and R&D Departments, a strong cross-collaborator is a must.

- In addition to future design iterations of lifecycle products, the individual will research, test/verify, and implement replacement of end-of-life components while maintaining the product design intent.

- In all work, the individual will contribute to risk management activities, dFMEA, pFMEA, and hazard analysis of lifecycle products.

- Travel overnight(s) as necessary both domestically and internationally to support project goals.

- Support/lead cross functional teams as lifecycle/sustaining engineering depending on the project scope. Liaison cross-functionally with stakeholders to drive alignment with project goals.

- Other duties as assigned by direct manager

Required Qualifications:

- Bachelor's degree in Biomedical, Mechanical, or Systems Engineering with minimum 2 years-experience

- Hands-on product development experience, demonstrated detail-oriented and organized behaviors

- High proficiency in SolidWorks & CAD modeling

- Tenacious problem solver; proven troubleshooting and root cause analysis skills in a fast-paced environment

- Effective technical and project lead skills to support project initiation through implementation

- Must be experienced with design and development aspects through all phases of product development

- Flexible, self-directed, organized, proactive and dependable

- Requires familiarity with Design for Manufacturing (DFM) and with rapid development of prototyping solutions

- Demonstrated excellent collaborative skills as part of a cross-functional team that includes lifecycle/NPI/procurement/manufacturing/regulatory/quality.

Preferred Qualifications:

- Ability to present a portfolio of work (business or academic) examples related to creative and novel product designs.

- Experience with component design and material selection as it relates to Design for Manufacturing (DFM)

- Experience with risk management tools including System Hazard Analysis (SHA) and Failure Mode and Effect Analysis (FMEA)

Other Requirements:

- This role is an on-site position in Cambridge, MA.

- Must be willing to travel domestic and/or internationally approximately 10% of the timeParagonix Technologies
Job Description - Lifecycle Design Engineer

Paragonix Technologies markets organ transportation devices that safeguard organs during the journey between donor and recipient patients. Our devices incorporate clinically proven and medically trusted cold preservation techniques in a novel suspension system to provide unprecedented physical and thermal protection. Paragonix

SherpaPak--- CTS is the only commercially available FDA cleared and CE marked transport device for heart transportation. Paragonix is also developing transport devices for the lung and kidneys designed to improve donor organ quality and extending donor organ transport time.

Reporting to the Vice President of Manufacturing, this position is a critical member of the manufacturing and supply chain operations team. This role is responsible for product lifecycle management, project management, resolving bottlenecks to capacity and supply, general continuous improvement of contract manufacturing partners, and vendor selection and qualifications. The successful candidate will focus efforts on sustaining and implementing breakthrough improvements to our market products and developing Paragonix's contract manufacturing supply chain.

Primary responsibilities will include:

* Lead and support root cause analysis for product failures, production challenges, and other issues as they arise.
* Develop/execute engineering project plans to reduce product risks and optimize resource utilization, including tooling qualifications, dual-sourcing projects, and continuous improvement cost reductions.
* Design iterations of existing products to improve quality, service, and cost.
* Design and set up feasibility tests to evaluate concepts, alternate materials, and changes within the production process.
* Author product qualification test protocols and report results.
* Interface frequently with external suppliers, consultants, and industry experts.
* Review documents and engineering change orders and maintain documentation control prior to release.
* Design test fixtures for product qualification using CAD and/or other technologies.
* Travel overnight(s) as necessary both domestically and internationally to support project goals.
* Support/lead cross functional teams as a mechanical engineering and/or supply chain representative depending on the project scope. Liaison cross-functionally with stakeholders to drive alignment with project goals.

Required Qualifications:

* Bachelor's degree in Mechanical Engineering or applicable engineering discipline required.
* 5+ years of manufacturing engineering experience within the medical device/technology industry.
* Working knowledge of medical device regulations (ISO 13485, ISO 14971, 21 CFR part 820), statistical analysis, and computer aided design
* Experience with design and process verification / validation required
* Experience with organized root cause analysis (5 Whys, Ishikawa, etc.) techniques
* Demonstrate excellent project team skills as part of a cross-functional team that includes development/procurement/manufacturing/regulatory/quality.

Preferred Qualifications:

* Advanced degree in an applicable engineering discipline preferred.
* Experience with Design of Experiments
* Experience with component design and material selection as it relates to Design for Manufacturing (DFM)
* Experience with risk management tools including System Hazard Analysis (SHA) and Failure Mode and Effect

Analysis (FMEA)

* Experience with projects involving domestic and international regulatory submissions
* Experience leading engineering projects utilizing Lean Manufacturing concepts.
* Six Sigma certification

Other Requirements:

* This role is an on-site position (post-pandemic)
* Must be willing to travel domestic and/or internationally approximately 15% of the time

Job Type: Full-time

Benefits:
* 401(k)
* Dental insurance
* Flexible spending account
* Health insurance
* Paid time off
* Vision insurance
Schedule:
* Day shift
* Monday to Friday
Supplemental pay types:
* Bonus pay

Education:
* Bachelor's (Required)

Experience:
* Mechanical Engineering: 2 years (Preferred)

Work Location: One location%58047475%

Keywords: Paragonix Technologies, Cambridge , Lifecycle Design Engineer, Other , Cambridge, Massachusetts

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