Staff Engineer - R&D Mechanical

What you will do:

• Interact with surgeon to collect VOC and analyze competitor systems to establish user needs.
• Utilize knowledge of surgical techniques to design & develop novel solutions addressing user and business needs for the Trauma Business.
• Fulfill key design control requirements including generating DIOVV, risk analysis, dFMECA and design reviews. Work with independent reviewers and quality assurance personnel to finalize and approve DCDs.
• Collaborate with Advanced Operations and vendors to DFM product designs and finalize drawings. Act as R&D representative for creation of DCPs and IGS.
• Conduct tolerance stack up analysis on developed design to verify product.
• Liaise with BML personnel to perform benchtop studies and execute test plans for devices.
• Visit division to conduct cadaver labs with surgeons in collaboration with Marketing.Partner with extended team to achieve PTQ milestones per established timelines.
• Assist regulatory affairs and marketing personnel in completing 510(k) and product launch deliverables.

What you need:

Must have

• 8 to 12 years of experience in product design preferably including 3 years of experience in medical device industry.
• Demonstrated ability to work on complex NPD projects - inception through launch - within tight timelines during at least 2 prior projects with Agile framework
• Expertise in CAD modelling and detailing using ProE and exposure to manufacturing processes, and inspection methods. Working knowledge of FEA using ANSYS Software.
• In depth understanding of GD&T as per ASME Y14.5, ASME GD&T certification highly desirable.

Good to Have

• Proven track record around working within a global team and employing excellent interpersonal, communication and presentation skills.
• Good understanding of ISO 14971. Design control, DHF knowledge.
• Educational Qualifications , Bachelors in Mechanical Engineering from a reputed institution.
• Mechanical prototyping and DFM mindset