Every is hiring a Senior R&D Engineer to lead complex, cross-functional initiatives with a focus on strategic projects like Global UDI implementation and Product Stewardship. The role includes managerial responsibility for R&D Sustaining requests, ensuring high-quality and timely delivery while navigating regulatory landscapes and driving process improvements.
What You'll Do
- 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.
- Write and review product development plans, design reviews, technical documents and reports.
- Prepare and approve verification and validation protocols and reports.
- Develop and implement 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 and develop elements for medical device processes, translating intangible design inputs into tangible engineering specifications and drawings.
- Make and present engineering decisions.
- Participate and lead cross-functional teams through design and development stages.
- Develop new processes by understanding key process inputs and outputs, using statistical methods such as DOE.
- Develop new process equipment and tooling, including specification development, vendor selection and negotiation.
- 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.
- Conduct engineering and competitor evaluations and develop unit testing.
- Plan, develop, execute and manage verification and validation activities for products and processes.
- 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.
- Mentor/coach R&D technicians and engineers through Sustaining activities.
- May supervise or manage technicians, engineers or supervisors, including team at HCL.
- May be asked to create and manage a project budget (expense and/or capital expenditure).
- Create and critique engineering cost analysis.
- 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.
What We're Looking For
- B.S. degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or other related engineering discipline.
- 6-9 years of industrial experience in R&D, preferably in medical device or other regulated FDA/QSR and ISO environment.
- 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 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.
- Training in Six Sigma or Design for Six Sigma.
Nice to Have
- Biomedical Engineering or Bioengineering degree preferred.
- Proficient in statistic software is a plus.
- Knowledge of cGMP and GLP is a plus.
Team & Environment
You will work within cross-functional teams, including offshore and local team members.
Work Mode
This is a local-country position based in IND Bengaluru - Technology Campus.
Every is an equal opportunity employer.
