Overview
Lead and support product development and cost-innovation initiatives for high-volume medical devices, delivering robust, compliant and manufacturable design solutions.
What you'll do
- Lead and support design and development activities for new products, product improvements, and critical component changes.
- Develop cost-saving concepts using VAVE, Lean Product Development, DFSS, DMAIC, Design of Experiments, statistical analysis, and Design for Manufacturability.
- Translate customer, user, operational, regulatory, and business needs into verifiable product requirements and maintain design traceability.
- Apply engineering first principles, analytical, computational, and experimental methods to evaluate design options, trade-offs, performance, reliability, and risk.
- Develop and execute verification strategies, test methods, measurement system analyses, and data analyses; prepare clear technical reports and engineering justifications.
- Author and review design-control and change-control documentation in accordance with applicable quality, regulatory, and safety requirements.
- Build integrated project plans, manage R&D deliverables, monitor progress, and ensure timely execution of project commitments.
- Collaborate with Marketing, Quality, Regulatory, Manufacturing Technology, Operations, and other stakeholders to support effective design integration and transfer.
- Lead technical reviews, assess relevant technologies, materials, intellectual property, products, and regulatory trends, and communicate recommendations.
- Mentor junior engineers and technicians, share technical knowledge, and foster an inclusive, innovative, and accountable work environment.
What you'll need
- Bachelor's degree in mechanical, Industrial, Production Engineering, or a closely related technical discipline.
- 8–10 years of experience leading or supporting product development projects in the medical device, pharmaceutical, or a related regulated industry.
- Hands-on experience designing and developing high-volume products and implementing product changes through a structured, phase-gated development process.
- Strong knowledge of medical-device design controls, change control, risk management, quality systems, and applicable regulatory requirements.
- Experience with VAVE, Lean Engineering, Lean Product Development, DFX, DFSS/DMAIC, statistical methods, and systematic problem solving.
- Strong cross-functional project leadership, planning, stakeholder management, and decision-making skills.
- Advanced technical problem solving with sound engineering and managerial judgment.
- Excellent written, verbal, presentation, interpersonal, coaching, and influencing skills in a matrix organization.
- Ability to work effectively through ambiguity, manage change, and balance user, quality, regulatory, technical, and business requirements.
- Collaborative team orientation and strong alignment with company values, safety standards, and quality expectations.
- Exposure to Minitab or any other equivalent statistical tool focused towards high volume manufacturing.
Nice to have
Details
- Primary work location: IND Bengaluru - Technology Campus.
Read the full description and apply on the company’s own careers page.