Lead Design Engineer

Education

• Full time Degree in a relevant engineering field is required (i.e., Mechanical, Industrial & Production, Chemical, Materials Engineering) or master's degree in a relevant engineering field is an added advantage.

Experience

• 7 - 12 years of experience in the engineering/technical field, with 3 years demonstrated project and team leadership, preferably in the medical device industry with a successful track record of project completion.
• Strong exposure to six sigma and lean methodologies would be an advantage. Candidates with prior experience in Medical Devices will be preferred.

Knowledge

• Six Sigma knowledge/Black /Greenbelt certification, DFSS, MSA
• PMP Certifications/Project Management knowledge
• ISO 20417, ISO 15223-1, ISO 13485, ISO 14971, ISO 62304
• Sustenance Engineering project delivery knowledge
• Statistics and Verification methods
• Tool knowledge SAP, Master control, JDE added advantage Exposure to CAD/CAE tools (Solid Works, AUTOCAD, PRO-E, etc.) specializing in mold flow, structural designs, CFD and plastics domain is desired.
• Good understanding of medical device product development risk management methodologies (EURA, FMEA, etc.) will be an added advantage.
• Expertise with test method development, validation strategy, and execution is required.
• Expertise with design verification & validation strategy development and execution is required.
• Expertise in fixture design & development.
• Strong track record of technical problem solving and effective product development through expert application of engineering principles is required.
• Design controls expertise and experience with traditional and modern fabrication techniques is required.
• Proven experience in leading CAPAs, design-defect analyses, remediation is required.
• Proficiency in solid mechanics/mechanics of materials and proficiency statistical methods/tools is required.
• Experience with design standard methodologies, including advanced tolerance design, and design for reliability.
• Working with regulatory standards
• Exposure to Chemistry/ Chemical Engineering and/or structural analysis and simulation/mathematical modelling desirable.

Skills

• Ability to lead and teach others to assess project/program needs, formulate strategy, build support, and execute initiatives.
• Strong interpersonal and influence skills.
• Ability to engage and mentor team members and to maximize diverse perspectives to achieve the best outcomes.
• Ability to analyze, organize and present large amounts of data in a clear and concise manner.
• Disciplined, detailed, and well organized with managing documentation in a regulated environment.
• Ability to execute concurrently multiple projects and manage priorities.
• Ability to work independently with global exposure is desired.
• Strong written and verbal communication skills.
• Advanced Problem-solving skills.
• Strong Cross-functional Project Leadership skills.
• Strong technical and managerial judgment.
• Team orientation.
• Strong skills in project planning and management.
• Broad and deep understanding of disciplined change control processes, regulatory, and quality requirements.
• Strong motivational fit.
• Strong fit with BD values.

Desired / Additional Skills & Knowledge (Not essential to the job but will be an advantage to possess)

• Experience in solid modelling (SolidWorks) or electromechanical systems is a plus.
• Experience in high-volume manufacturing processes is a plus.
• Experience developing and commercializing medical devices is a plus.
• DFSS training or certifications are a plus.