About the Position –
Mechanical Design Engineering Manager will drive the design and engineering solutions for high-volume medical device products. He / She will provide mentorship to a team of engineers to deliver solutions for the new and existing products through design iterations, risk-retirement planning using principles of engineering, technical analyses / FMEA with validation & verification of the design. Learning of current engineering practice at Phoenix’s Product Development System & engineering tools will be necessary to deliver a high quality, robust and cost-effective design and will partner cross-functionally to execute all aspects of product development. He / She will also ensure successful design-transfer into manufacturing.
Mechanical design Manager must be persistent and have strong problem-solving skills. He / She should also be creative enough to generate innovative ideas and bring them to fruition.
The position involves balance of direct design ownership and working with the teams to get desired outcomes & productivity.
► To Build & Lead the design, development and testing of mechanical sub-systems for electro-mechanical device and accessories for Phoenix Products.
► Develop new design solutions & drive innovation. Ideation, design and hands-on prototyping and feasibility testing of design concepts.
► Participate in design efforts over the continuum of product development; Coordinate, deliver, plan & communicate R&D deliverables on the program and maintain collaborative relationships with the cross-functional team (i.e Marketing, Quality, Regulatory, Manufacturing Technology, Operations etc).
► Identify, evaluate and drive development projects with suppliers and partners.
► Will have the direct responsibility of part lifecycle management for mechanical parts & sub-systems. Create & maintain design documentation (BOM’s, Specifications, Drawings, Traceability)
► Resolve technical problems. Create solutions for technical problems using systematic problem-solving methodologies and engineering principles.
► Follow Design Control for medical devices to ensure compliance with all local, state, federal, international, and internal safety regulations, policies, and procedures.
► Supports internal and external regulatory audits . Facilitates cross functional team problem solving continuous design improvement projects.
► Ensure the design considerations are embedding all applicable DFX (Design for Excellence) aspects including manufacturability, serviceability, reliability and safety.
Skills and Qualifications :
► BE / M Tech in Mechanical Engineering. Candidates from leading engineering colleges with strong technical aptitude would be prefered.
► Minimum 7 years of experience leading / supporting product development projects in Medical or Automotive or Electronics devices & Mechanical design. Candidates with prior experience in Medical Devices, Aerospace, Automotive will be preferred.
► Hands-on skills with the proven ability to independently apply deep technical knowledge to lead complex mechanical designs.
► Required to have experience in complete product lifecycle i.e. from product conceptualization to design development and manufacturing including Customer Service of medical devices
► Strong design skills. Exposure to CAD/CAE tools (Solidworks, AUTOCAD, PRO-E, etc)
► Good understanding of medical device product development risk management methodologies (EURA, FMEA, etc.)
► Electro-mechanical integration and electronics exposure.
► Solid understanding of general manufacturing processes like injection molding & machining with experience in tool engineering and design.
► Experience in Vendor management, component / material selection with experience in part / sub-assembly design development, prototyping and verification.
► Strong Knowledge & understanding of medical device regulations like ISO13485, EU MDD & US FDA 21 CFR 820 & standards requirements like IEC60601, ISO14971, IEC62304 etc.
► Strong presentation skills. Excellent written and verbal communication
► Team management and leadership skills
Required Experience –
Min 7 Years of product Design & Development in a Product Engineering set up for global Electronics / Automobile / Medical Systems company. Should have been part of team which would have delivered at least ONE product successfully to the market.
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