Lead, Product Engineering, MedTech Catapult
Salary undisclosed
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Job Responsibilities:
Lead and manage diverse engineering team to translate technologies through product development and engineering across a full-life cycle of product development and from proof of concept/feasibility to pilot production
Execute complex engineering projects by applying deep working knowledge of the technology trends - emerging technologies, sustainiblity, bringing teams through design & development, risk analysis, verification and validation whilst applying best practices for development and testing in terms of design patterns, reusable components, and automation etc as applicable.
Lead the development of intellectual property portfolio in device design and process technology know-how.
Knowledgeable in industry standards and regulation and author/guide policies, procedures, including coaching of new employees;
Work with both internal and external stakeholders to define project plans and budgets, develop and maintain project timelines, establish and monitor project risks and risk register and lead the project teams to achieve project deliverables and objectives in accordance to ISO 13485.
Interface with external parties (design houses) to communicate product requirements, and subsequent knowledge transfer to build internal capability
Review and approve documentations for QMS, approve risk analysis, risk management, verification and validation procedures.
Apply disciplined, fact-based judgment to process recommendations.
Consistently demonstrate structured thinking
Manage resources allocated to the PU efficiently
Requirements:
M.S in Electrical Engineering, Computer Engineering or Mechanical Design
15+ years of experience in medical device industry in R&D, and/or related area
Experience in the areas of design for lean six sigma, Quality through design, Extreme programming and Systems Engineering
Experience with hardware or software design and development and associated skills relating to QMS, design and developing and testing
Experience with product development and design control from research/concept to product manufacture for at least 3 products, experience with SaMD
Up to date with latest QA/RA requirements i.e. country regulations, standards
Solid knowledge of regulatory standards such as ISO13485, ISO14971, 21 CFR Part 11, IEC 60601, IEC 62304 and AAMI standards applicable to medical devices and software.
Ability to own supplier/vendor relations including evaluation and coordination
Demonstrated experience managing a diverse technical team with budgetary responsibility
Possess excellent networking, communication and writing skills
Demonstrate ability to juggle priorities and meet deadlines
Excellent written and verbal communication skills
Enjoy working in a small team, start-up environment
The above eligibility criteria are not exhaustive. A*STAR may include additional selection criteria based on its prevailing recruitment policies. These policies may be amended from time to time without notice. We regret that only shortlisted candidates will be notified.
Type of Employment : Full-Time
Minimum Experience : 15 Years
Work Location : Biopolis
Lead and manage diverse engineering team to translate technologies through product development and engineering across a full-life cycle of product development and from proof of concept/feasibility to pilot production
Execute complex engineering projects by applying deep working knowledge of the technology trends - emerging technologies, sustainiblity, bringing teams through design & development, risk analysis, verification and validation whilst applying best practices for development and testing in terms of design patterns, reusable components, and automation etc as applicable.
Lead the development of intellectual property portfolio in device design and process technology know-how.
Knowledgeable in industry standards and regulation and author/guide policies, procedures, including coaching of new employees;
Work with both internal and external stakeholders to define project plans and budgets, develop and maintain project timelines, establish and monitor project risks and risk register and lead the project teams to achieve project deliverables and objectives in accordance to ISO 13485.
Interface with external parties (design houses) to communicate product requirements, and subsequent knowledge transfer to build internal capability
Review and approve documentations for QMS, approve risk analysis, risk management, verification and validation procedures.
Apply disciplined, fact-based judgment to process recommendations.
Consistently demonstrate structured thinking
Manage resources allocated to the PU efficiently
Requirements:
M.S in Electrical Engineering, Computer Engineering or Mechanical Design
15+ years of experience in medical device industry in R&D, and/or related area
Experience in the areas of design for lean six sigma, Quality through design, Extreme programming and Systems Engineering
Experience with hardware or software design and development and associated skills relating to QMS, design and developing and testing
Experience with product development and design control from research/concept to product manufacture for at least 3 products, experience with SaMD
Up to date with latest QA/RA requirements i.e. country regulations, standards
Solid knowledge of regulatory standards such as ISO13485, ISO14971, 21 CFR Part 11, IEC 60601, IEC 62304 and AAMI standards applicable to medical devices and software.
Ability to own supplier/vendor relations including evaluation and coordination
Demonstrated experience managing a diverse technical team with budgetary responsibility
Possess excellent networking, communication and writing skills
Demonstrate ability to juggle priorities and meet deadlines
Excellent written and verbal communication skills
Enjoy working in a small team, start-up environment
The above eligibility criteria are not exhaustive. A*STAR may include additional selection criteria based on its prevailing recruitment policies. These policies may be amended from time to time without notice. We regret that only shortlisted candidates will be notified.
Type of Employment : Full-Time
Minimum Experience : 15 Years
Work Location : Biopolis