Design Engineer

Job Overview:

We are seeking talented professionals to join our Research and Development (R&D) team in various roles. As a key member of our team, you will be responsible for driving innovation and excellence in product development.

• Key Responsibilities:

• Create a Quality culture by driving compliance activities around specific products, sites, or regions.

• Ensure quality and regulatory compliance while driving process effectiveness and efficiency.

• Represent the company externally and champion the evolution of the quality culture.

• Organize and drive rigorous compliance of Quality Management Systems (QMS) processes at a medical device facility.

• Communicate complex messages and negotiate with others to adopt different viewpoints.

• Use high-level judgment to make decisions and handle complex tasks or problems that impact site compliance.

• Assess the quality of information given and ask pertinent questions to stakeholders.

• Offer new solutions to problems outside set parameters and construct recommendations.

• Develop comprehensive procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product and process-related documentation.

Requirements:

• Minimum of Bachelor's Degree.

• Experience in establishing Design Quality Control, Assurance, Regulatory Affairs teams & competence development from scratch within a regulated industry.

• Ability to effectively communicate technical information in English (both written and oral).

• Experiences in understanding & interpretations of Risk Management, Design Controls, Standards & Regulations, CDSCO, FDA, MDSAP, etc. for Class 2 and Class 3 devices.

Additional R&D Roles:

• Mechanical Engineering Role:

• Opportunity to work from scratch, responsible for development of Lab Infrastructure, New Products, Installed Base, and Advanced Technology Developments.

• In-depth knowledge of best practices and how own area integrates with other functional areas that would help in building products.

• Working knowledge of competition and factors that differentiate them in the market.

• Uses judgment to make decisions or solve moderately complex tasks or problems in areas of operational/product management, manufacturing, technology, or engineering.

• Acts as a resource for colleagues with less experience.

• Leads small projects with moderate risks and resource requirements.

• Explains difficult or sensitive information; works to build consensus.

• Developing persuasion skills required to influence others on topics within the field.

• Experiences of Plastics, Casting, Simulations & Modelling.

• This role requires experience in the Mechanical Engineering/Technology & Design Engineering Management.

• Masters Degree or Bachelor's Degree in Engineering (specialized in Mechanical / Manufacturing) or Physics, or equivalent experience.

• Relevant Medical Devices Design work experience in New Product Development.

• Embedded Hardware Engineering.

• Expertise in India & global Medical Devices Design Controls, Quality Management System, Standards & Regulations, such as ISO 13485, 60601, 14971, etc.

• Lead/contribute to Electrical & Electronics technical solutions and products.

• Lead/contribute to a project team, a tiger team, or a process improvement initiative.

• Design, analyze, integrate, and document products, systems, or subsystems.

• Provide technical guidance and oversight to include concept development and peer/design review participation.

• Support verification testing, transition to production, and field issue resolution.

• Provide budget, cost, and schedule input.

• Participate in proposals.

• Mentor engineers/designers.

• Support, communicate, reinforce, and defend the mission, values, and culture of the organization.

• Inspire team's engagement in all phases of product development.

Required Skills and Qualifications:

• Bachelor/Master of Science in STEM (Electrical & Electronics engineering preferred).

• Professional experience in hands-on project, 5+ years in people leadership within a product development or research development environment.

Software Engineering Role:

• Execute on the organization's strategy, providing clearly defined success criteria and levels of accountability for individuals in the team.

• Removes impediments for the progress of the teams and acts as escalation point.

• Focuses on customers by understanding their needs to design and implement solutions.

• Consistently delivers high-quality software at a sustainable speed, maintaining an advanced level of software craftsmanship as established by the SW CoE.

• Ensures adherence to all applicable development processes, Standards & Regulations, Cyber security, legal, quality, security, and regulatory requirements.

• Being a Technical, Hands-on Subject Matter Expert in the field of Software Engineering, including Embedded Software Engineering.

• Contributes to the technical innovation of the product and/or systems which the teams are accountable for by providing insights, hands-on technical reviews, and continuous feedback.

• Stays up-to-date on the relevant technology domain. Enjoys self-learning and brings new technical practices and innovations to the team.

• Collaborates with relevant internal and external parties establishing an effective network to obtain input on technological developments, identifying trends, and opportunities.

• Executes on continuous improvement in processes and ways of working to achieve operational excellence.

• Makes informed business and technical decisions quickly as the result of well-directed data gathering, effective analysis, and good judgment.

• Balancing the tension between daily tasks and the long-term strategic vision of the organization.