Staff Engineer - R&D Mechanical

Product Design Engineer

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.

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

Travel Percentage: 20%