Job Description Summary

Seeking a high-level R&D Manager/Associate Staff 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 help execute, 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 both execution of tasks, as well as managerial responsibility to ensure R&D Sustaining requests and Product Stewardship initiates are delivered upon with high quality and timeliness.
Requires a high-energy individual with excellent teamwork, partnering and negotiation skills. Must demonstrate good judgment in selecting methods and techniques for obtaining solutions. High level and hands-on engineering position that leverages medical device development / quality / manufacturing experience.

Excellent technical, verbal and written communication skills, detail orientation and analytical/problem solving skills are a must. Must be a highly motivated self-starter with the ability to achieve results with minimal direction.

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, develops and implements new products and processes of a medical device, translating intangible design inputs into tangible engineering specifications and drawings. Makes and presents engineering decisions. Participates and leads cross-functional teams in the design of a medical device. Contribute ideas and/or generate intellectual property submissions. 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, process development, department and division procedures 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.May conduct performance reviews, recommend salaries and promotions, training, interviewing and hiring decisions, and disciplinary actions. Fiscal: May be asked to create and manage a project budget (expense and/or capital expenditure). Create and critique engineering cost analysis.  Reviews and analyzes costs to identify and implement cost improvements.

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: 10+ years of industrial experience in R&D, preferably in medical device or other regulated FDA/QSR and ISO environment. (Masters degree plus with 6-8 years, medical device or equivalent industry experience).
• Demonstrated hands-on technical aptitude.
• Proficient in project management tools and methodologies
• Demonstrated proficiency in mechanical design, tolerance stack-up analysis, design for Manufacturability (DFM) / Design for Six-Sigma (DFSS), and specification development.
• Experience in process validation (IQ, OQ and PQ), writing protocols and reports to support verification and validation activities; creating/executing project plans; ability to execute validation; rapid prototyping; basic tooling, design and drafting knowledge.
• Excellent oral and written communication skills.
• Ability to analyze data, interpret results, and write reports. Proficient in statistical software for experimental design and analysis techniques.
• Training in Six Sigma or Design for Six Sigma.
• Impeccable documentation skills and adherence to design control procedures and GLP
• Ability to lead cross functional teams, across multiple time zones.
• Managerial experience overseeing teams – onsite and remote
• Comfortable in a dynamic working environment

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: 10+ 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 6-8 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