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Sr Design Engineer

Expired Job

Tephra Inc. Raynham , MA 02767

Posted 2 months ago

This profile will require the candidate identified to take up role within R&D department of Orthopaedic Medical Device major and provide consulting services in Design Engineering .The candidate should be experience in end-to-end product development and must have Project Management background.


Experience in Medical Device Product Development
Experience in coordinating with offshore teams, preferably experience of working with teams in India
Expertise in CAD software UG NX and Teamcenter Engineering or similar CAD software is must
Experience in tolerance stack up analysis, FEA analysis, concept development
Experience of working through Design Control Process for NPD
Exposure to Medical Device Risk Management per ISO 13485. Hands on experience in Design Failure Mode and Effect Analysis (DFMEA)
Significant experience of Project & Program Management concepts, and the associated tools
Exposure to Design Verification and Validation activities
Good understanding of Medical Device QMS and Design Quality requirements
Understanding of Design History File (DHF)
Basic understanding of regulatory pathways in various key geographies for various classes of medical devices
Significant grasp over key concepts, requirements & terms associated with product re-certification activities for FDA, BSi & MDD-EEC.
Orthopaedic and Spine Product knowledge will be an advantage
Software skills Should be proficient with Microsoft PowerPoint, Microsoft Excel & Microsoft Project Plan

Responsibilities:
Take ownership and draft various aspects of DHF
Conceptualize new design and propose creative solutions to solve design problems
Ensure compliance with statutory or company regulatory requirements
Ensure Design Verification and Validation is performed to demonstrate safety and efficacy of new design
Plan and execute Risk Management and perform DFMEA
Interact with all levels of company management, external experts and vendors
Assume responsibility for own commitments & delivering to agreed timescales per project deadlines
Provide updates to company management regarding work performed & deliverables
Create and manage Engineering Change Orders if required
Make use of the offshore team, based in various locations, with prior approval of the concerned line manager(s)

Qualifications:
BS in Engineering

Years of experience required for position 4-10

Location for the position Raynham, MA, USA This profile will require the candidate identified to take up role within R&D department of Orthopaedic Medical Device major and provide consulting services in Design Engineering .The candidate should be experience in end-to-end product development and must have Project Management background.

Experience in Medical Device Product Development
Experience in coordinating with offshore teams, preferably experience of working with teams in India
Expertise in CAD software UG NX and Teamcenter Engineering or similar CAD software is must
Experience in tolerance stack up analysis, FEA analysis, concept development
Experience of working through Design Control Process for NPD
Exposure to Medical Device Risk Management per ISO 13485. Hands on experience in Design Failure Mode and Effect Analysis (DFMEA)
Significant experience of Project & Program Management concepts, and the associated tools
Exposure to Design Verification and Validation activities
Good understanding of Medical Device QMS and Design Quality requirements
Understanding of Design History File (DHF)
Basic understanding of regulatory pathways in various key geographies for various classes of medical devices
Significant grasp over key concepts, requirements & terms associated with product re-certification activities for FDA, BSi & MDD-EEC.
Orthopaedic and Spine Product knowledge will be an advantage
Software skills Should be proficient with Microsoft PowerPoint, Microsoft Excel & Microsoft Project Plan

Responsibilities:

Take ownership and draft various aspects of DHF
Conceptualize new design and propose creative solutions to solve design problems
Ensure compliance with statutory or company regulatory requirements
Ensure Design Verification and Validation is performed to demonstrate safety and efficacy of new design
Plan and execute Risk Management and perform DFMEA
Interact with all levels of company management, external experts and vendors
Assume responsibility for own commitments & delivering to agreed timescales per project deadlines
Provide updates to company management regarding work performed & deliverables
Create and manage Engineering Change Orders if required
Make use of the offshore team, based in various locations, with prior approval of the concerned line manager(s)

Qualifications:
BS in Engineering
Years of experience required for position 4-10

Location for the position Raynham, MA, USA

Skills:
Medical Device Product Development, UG NX, NPD, QMS, DHF
Permanent


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Sr Design Engineer

Expired Job

Tephra Inc.