Job Description Summary

Seeking a senior level engineer who is a highly organized and results-driven professional with strong project management skills to lead complex, cross-functional initiatives. Primary focus of this position is to oversee and support strategic projects including Global UDI implementation, Product Stewardship (covering SDS, REA, PFAS/REACH, RAM, SVT, etc.), Lot Grading, Microplastics, Canadian Plastics compliance, etc. Role includes managerial responsibility to ensure R&D Sustaining requests and Product Stewardship initiates are delivered upon with high quality and timeliness.

The candidate should be comfortable navigating regulatory landscapes, driving process improvements, and collaborating with diverse stakeholders to deliver impactful outcomes. Candidate shall have experience in data mining and analytics and be adept at managing offshore teams to ensure seamless execution across global time zones. Position requires flexibility in starting time to support teams in different time zones.

Position may also be asked to work on projects involving: developing, optimizing, implementing, and validating components/elements of a medical device. The candidate may perform hands-on testing in optimization of a device; conduct process development activities to understand process inputs and outputs; assist/write technical documents, validation protocols and reports; prepare work instructions and standard operating procedures; assist in conducting design and process qualification and validation; support equipment development; support other activities from R&D, Quality, Operations, and Regulatory Affairs.

Job Description

Essential / Key Job Responsibilities (including supervisory and/or fiscal):

Project Management: Lead offshore/local teams for end-to-end data initiatives for the R&D Sustaining group, including Product Stewardship and Corporate Requests.  Extract, collect, analyze, and summarize data files and report to stakeholders.Documentation & Compliance: Main focus on documentation needed to support strategic projects. Write and review product development plans, design reviews, technical documents and reports. Prepares and approves verification and validation protocols and reports. Develops and implements procedures/policy, work instructions and standard operating procedures.  Prepare raw material specifications and drawings. Lead strategic projects across cross-functional teams to ensure compliance. Design: Designs and develops elements for medical device processes, translating intangible design inputs into tangible engineering specifications and drawings. Makes and presents engineering decisions. Participates and leads cross-functional teams through design and development stages. Process Development: develops new processes by understanding key process inputs and outputs, using statistical methods such as DOE as appropriate. Develops new process equipment and tooling, including specification development, vendor selection and negotiation. Test Method Development: develop new engineering test methods and clinically relevant simulated use test methods in conjunction with R&D technicians; prepare and assist in the validation of test methods. Testing: conduct engineering and competitor evaluations and develop unit testing. Plan, develop, execute and manage verification and validation activities for products and processes. Training: train technicians and engineers on new design and process development as well as new test methods. Conduct new hire training and any associated training oversight for technicians and engineers. Supervisory/mentoring/coaching: Mentor/coach R&D technicians and engineers through Sustaining activities. May supervise or manage technicians, engineers or supervisors, including team at HCL. Fiscal: May be asked to create and manage a project budget (expense and/or capital expenditure). Create and critique engineering cost analysis.

Other Responsibilities may include, however are not limited to:

• Support Manufacturing, Quality, Regulatory & R&D to ensure systems are compliant with all internal and external guidelines.
• Support/lead design and process root cause analysis and support non-conforming product and complaint investigations.

Required Qualifications:

• B.S. degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or other related engineering discipline.  Biomedical Engineering or Bioengineering degree preferred.
• Experience: 6-9 years of industrial experience in R&D, preferably in medical device or other regulated FDA/QSR and ISO environment. (Masters degree plus with 4-6 years, medical device or equivalent industry experience).
• Demonstrated hands-on technical aptitude.
• Proficient in project management tools and methodologies
• Experience in process validation (IQ, OQ and PQ), writing protocols and reports to support verification and validation activities for product commercialization; ability to execute validation.
• Ability to create and execute project plans.
• Ability to lead cross functional teams, across multiple time zones.
• Managerial experience overseeing teams – onsite and remote
• Basic tooling, design and drafting knowledge.
• Excellent oral and written communication skills.
• Ability to analyze data, interpret results, and write reports. Proficient in statistic software.
• Training in Six Sigma or Design for Six Sigma.

Preferred Qualifications:

• Ability to analyze data, interpret results, and write reports. Proficient in statistic software is a plus.
• Knowledge of cGMP and GLP is a plus.
• Training in Six Sigma or Design for Six Sigma is a plus.

Education and/or Experience:

• B.S. degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or other related engineering discipline.   Biomedical Engineering or Bioengineering degree preferred.
• Experience: 6-9 years of industrial experience in R&D or process development, preferably in medical device or other regulated FDA/QSR and ISO environment (Masters degree plus with 4-6 years, medical device or equivalent industry experience).

Required Skills

Optional Skills

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Primary Work Location

IND Bengaluru - Technology Campus

Additional Locations

Work Shift