Work Flexibility: Hybrid

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

Travel Percentage: 20%