Staff Product Support Engineer (Electro-Mechanical)-Medical Device

Smith & Nephew - Andover, MA (30+ days ago)3.7

General Summary:
Seeking self-motivated disciplined individual for a Senior level position responsible for supporting Life Cycle, Safety and Compliance Engineering for Arthroscopy and Technology Business Unit. Individual must be able to work with minimal oversight on a variety of complex medical electronic products as it relates to compliance and sustainability.

Essential Job Functions:
Perform engineering functions to maintain existing products as it related to involving safety, regulatory (FDA and MDD) and environmental compliance (RoHS and REACH).

Ability to lead a development effort involving hardware, software and system level configurations.

Seeks new technologies for integration into new products. Assist in new product development.

Develop verification and validation protocols.

Provides technical support to other groups as required to bring a product successfully through commercialization, helps maintain existing products and supports vendor technical requirements.

Perform design control functions to ensure compliance with FDA, ISO and IEC guidelines.

Ability to work with PCB design platform such as OrCAD.

Scope Of Position Responsibilities:
For Supervision:
May provide guidance to one or more junior engineers or technicians.

For Internal and External Relationships

Will work with cross functional teams of all visualization projects. Will be required to work closely with external consultants and vendors.

Familiarity with hardware testing and development tools.

Preparation of written design, specification, and verification documents.

Perform product design validation

Ability to work within the PLM environment (SAP)

Ability to work under minimal direction.

Good written and verbal communication skills, ability to work as part of a cross functional team.

Good organizational skills.

Ability to learn and put into practice the good engineering development process including FDA and IEC Guidance.

B.S. in Electrical, Mechanical, or related engineering discipline

6+ years of electronics, hardware, or compliance engineering experience required.

Hands-on and demonstrated design experience in one or more of the following areas:

Hardware design
Oversight of PCB design/layout for manufacture
Familiarity with design control practices
System level design
EMC/EMI testing and remididation techniques
Sustaining Engineering
Compliance Engineering
Experience with FDA Good Manufacturing Practice and MDD

Experience with design controls, preferably in the medical device industry.

Experience with PLM tools, e.g., SAP, SolidWorks, AutoCad, etc.

Experience with compliance and standards, e.g., IEC60601-1, IEC 62304, IEC 62366.

Experience with productivity tools, Microsoft Office, etc.

The above job description is intended to describe the general content, identify the essential functions of, and requirement for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or requirements.