Manufacturing Engineer

Position: Staff Manufacturing Engineer
Atri Cure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons around the globe use Atri Cure technologies for the treatment of Afib and reduction of Afib related complications. Atri Cure's Isolator Synergy Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib.

Atri Cure's Atri Clip Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. Atri Cure's Hybrid AF Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. Atri Cure's cryo

ICE cryo

SPHERE probe is cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures. For more information, visit  or follow us on Twitter @Atri Cure.

We foster a culture of inclusion by embracing diverse experiences and individuals where everyone's authentic self is welcome. We offer supporting programs and resources that provide enriching and equitable opportunities for each person to contribute professionally and personally.

POSITION SUMMARY:

The Staff level Manufacturing Engineer is a highly experienced manufacturing/process engineer, responsible for developing, validating and maintaining capable and stable manufacturing processes to meet product quality standards/requirements. The role is responsible for defining the manufacturing processes required to bring new products to market, both internally at Atri Cure, and externally at key suppliers, as well as defining and implementing improvements to existing manufacturing processes.

A Staff Manufacturing Engineer may lead project teams and will contribute to the coaching and development of less senior engineers.

ESSENTIAL FUNCTIONS OF THE POSITION:

* Ensures continuous improvement in process, cost, quality and production

* Responsible for coaching/mentoring members of the Manufacturing/Process Engineering Teams

* Supports and drives a DFM focused culture within the PD teams and the operations organization

* Supports and drives a continuous improvement culture within the PD teams and the operations organization

Represents manufacturing on cross functional projects, both internal and external. Specific expectations include:

* Defines high level manufacturing system/flow requirements and selects appropriate manufacturing processes to achieve required tolerances, production capacities, and cost targets.

* Collaboration with product design engineers to identify and implement Design for Manufacture/Design for Assembly improvements.

* Has knowledge of tolerance capabilities of processes such as machining, molding, casting, stamping, forming, grinding, etc. Understands GD&T and how to properly apply it to yield the desired fits between joining parts

* Applies lean manufacturing (Toyota production system) principles to the design of manufacturing processes, facilities layouts and business processes associated with manufacturing.

* Participates in development of product requirements and leads manufacturing risk management activities (Process FMEA, Validation Master Plan, Inspection and Test methods)

* Selection of suppliers for parts and equipment.

* Coordination of prototype and pre-production builds.

* Specifies, designs and manages procurement of equipment, fixtures and tooling.

* Applies project management best practices to manufacturing engineering projects including development of work breakdown structures, identification of required resources, budgeting and management of required expenses, and daily task and resource management to achieve expected project outcomes.

ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:

* Regular and predictable work performance

* Ability to work under fast-paced conditions

* Ability to make decisions and use good judgment

* Ability to prioritize various duties and multitask as required

* Ability to successfully work with others

* Additional duties as assigned

BASIC QUALIFICATIONS:

* Bachelor's degree in Industrial Eng., Biomedical Engineering or Mechanical Eng. or equivalent is required

* 10+ years of related experience:

* Experience in development of new manufacturing processes and the tooling/equipment required to implement the processes

* Knowledge base in Lean Processes and Continuous Improvement

* Experience in Design for Manufacturability

* Experience with medical device design and manufacture

* Previous class II or class III Medical Device manufacturing experience

* Possess a strong knowledge of manufacturing processes and capabilities. Provide guidance in process and supplier selection when necessary.

* Self-motivated with strong time management skills

* Ability to translate broad strategies into specific objectives and action plans

* Experience in technical report writing and verbal and oral communication skills

* Must be able to read blue prints and interpret technical…