Advisory Mechanical Engineer

ZOLL Services LLC (on SAM site) • Pittsburgh, PA • 3h ago

CMSAt ZOLL, we're passionate about improving patient outcomes and helping save lives. We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions.

ZOLL Cardiac Management Solutions offers a unique portfolio of novel technologies designed to deliver better insights and better outcomes. On any given day, clinicians utilize these ZOLL products for tens of thousands of cardiac patients around the world:

LifeVest, the world's first wearable defibrillator, has been trusted to protect more than 1M patients at risk of sudden cardiac death.

HFMS (Heart Failure Management system) is a non-invasive, patch-based device that monitors pulmonary fluid levels and has been shown to reduce heart failure readmissions rates by 38 percent.

TherOx Super Saturated Oxygen (SSO2) Therapy is the first FDA-approved therapy since the stent 20+ years ago to reduce infarct size in patients with the most severe heart attacks.

Heart disease is the leading cause of death for both men and women in the U.S. At ZOLL, your work will help to ensure cardiac patients get the life-saving therapy they need.

ZOLL has been Pittsburgh's Manufacturer of the Year, one of Western PA's Healthiest Employers, and even one of Pittsburgh's Coolest Offices. But it's our unique opportunity to impact people's lives that makes ZOLL the ideal place to build your career.

Job Type

Hybrid

Job Summary

Lead engineer responsible for the mechanical design and development of ZOLL's life-saving medical devices. This includes definition, design, implementation, debug, test, and post-production support in a regulated environment. Also provides coaching and mentoring of associates within Mechanical Engineering. Additional responsibilities include development and maintenance of design documentation; participation in technical reviews, work planning, and estimation; and providing technical support to other internal cross-functional groups. May also lead or support research, design, and technical feasibility projects. The Advisory Mechanical Engineer is an individual who can provide cross-functional technical leadership on our projects. This position requires the candidate to possess a high level of creativity, to apply advanced knowledge of engineering principles, and to provide project technical leadership.

Essential Functions

Employs the appropriate level of engineering rigor to mechanical designs ensuring product robustness, reliability, and patient safety.

Designs complex plastic injection molded parts with an understanding of best practices, material selection, tooling, and troubleshooting.

Utilizes 3D Computer Aided Design (CAD) software with an advanced understanding of advanced modeling techniques.

Employs CAE simulation software to verify design element(s) including but not limited to FEA, CFD, and mold flow.

Designs electro-mechanical assemblies and mechanisms.

Creates 2D engineering drawings per ASME Y14.5 standards.

Generates and processes Engineering Change Orders.

Conducts tolerance analysis of complex mechanical assemblies.

Leads design reviews with a high level of scrutiny and thoroughness.

Designs body-worn mechanical enclosures for EMI/RF containment and environmental constraints, specifically ingress protection (IP66/67).

Consults with Human Factors and implements usability and preference attributes to mechanical designs, including soft goods and garments.

Defines, plans, and executes project-related deliverables while effectively communicating to the appropriate stakeholders within the organization.

Leads or supports advanced development technical feasibility studies for future-generation products.

Conducts product failure investigations, root cause analyses, andDesign of Experiments (DOE) processes for sustaining engineering activities.

Supports Supplier Quality Engineering (SQE) with Medical Process Validation activities.

Researches new products, tools, components, technologies, and processes; develops and demonstrates proto@types; and recommends a course of action.

Works closely with Project Management to plan and track project status.

Coaches other engineers and delegates aspects of projects to them.

Uses interpersonal skills to coordinate with internal and external teams effectively.

Required/Preferred Education and Experience

BS degree in Mechanical Engineering or a related discipline required.

Typically 15+ years related industry experience with progressively increasing responsibility, including a track record of successful project completion.

Knowledge, Skills and Abilities

Advanced understanding and working knowledge of various manufacturing processes and fabrication methods (e.g. machining, casting, sheet metal, adhesives) and their associated limitations, benefits, and tradeoffs.

Advanced proficiency with PLM/PDM (Windchill preferred).

Advanced user of SolidWorks and/or Creo (Mastery level).

Advanced knowledge and/or application of Finite Element Analysis (FEA) software (ANSYS preferred).

Medical Device or regulated industry experience preferred.

Body-worn (wearable) electronic design for textiles and soft goods a plus.

General experience with Microsoft Office (Word, Excel, etc.).

Must have excellent communication skills, both verbal and written.

Advanced application of Geometric Dimensioning and Tolerancing (GD&T) preferred.

Six Sigma Green Belt Certification preferred.

Experience with project management and technical leadership (preferred).

Travel Requirements

10% as needed.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Standing - Constantly

Walking - Constantly

Sitting - Occasionally

Lifting - Constantly

Carrying - Constantly

Pushing - Constantly

Pulling - Constantly

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