Job Description:
Phillips-Medisize, India is seeking a Product Design Engineer to design and develop drug delivery medical devices, following the Phillips-Medisize Design Development Process (DDP) and applicable standards such as ISO 13485 & ISO 14971 with design controls.
Responsibilities:
- Operate primary CAD systems such as SolidWorks or Creo
- Identify and analyze design risks using tools such as tolerance stack-up analysis, FEA and design calculations.
- Develop appropriate design risk mitigations and test strategies using dFMEA & pFMEA
- Design, development, prototype and testing of concepts.
- Develop assembly and test fixtures to aid in the manufacture and testing of the design.
- Develop appropriate drawings to detail part and assembly specifications in a manner compliant with ASME Y14.5 & ISO 1101.
- Generate Engineering Change records following change management process.
- Ensure that design inputs and outputs are properly documented and controlled according to relevant SOP, WI process.
- Development of test methods and plan for verification of mechanical design specifications.
- Design/selection of materials for components used in drug delivery medical devices such as springs, elastomers, plastic parts, sheet metal components.
- Selection of material for plastic, metal, elastomeric parts that interacts with the drug.
Required Qualifications:
- BE/B. Tech in Mechanical Design or Mechanical Engineering or Mechatronics
- 2-4 years of experience in the design and development of medical devices preferably drug delivery medical devices such as pen injectors, auto-injectors, wearable pumps etc.
- Expertise in Plastic injection molding process and new product development.
- Design for Manufacturability (DFM) experience focusing on plastic injection molding and plastic assembly methods (snaps, ultra-sonic welding, press fit, sealing, bonding, etc)
- Familiarity with Design controls in compliance with 21 CFR 820.30.
Skills And Abilities
- Familiar with ISO 13485 and ISO 14971
- Ability to generate complex solid & surface models.
- Familiar with various plastic materials and their design limitations.
- Strong written and verbal communication skills; ability to communicate design intent to a diverse audience.
- Demonstrates strong ability to evaluate and recommend appropriate prototyping processes (i.e. SLA, printed, machined, molded)
- Maintains and respects customer, project, and program confidentiality.
- Motivated self-starter who is able to manage multiple tasks.
We offer you
- A challenging position in an international innovative and successful company that is growing.
- An opportunity to become part of a global team of dedicated and highly qualified colleagues based in Bangalore, India.
- Well-structured training and continuous development of your competencies.
- Exciting career possibilities within the constantly growing area of medical devices
The Company In Short
Phillips Medisize is an expert in the design, development and delivery of advanced drug delivery devices and connected health solutions. Our customers are leading pharmaceutical companies worldwide. We offer innovative and integrated solutions supported by an end-to-end service offering from Strategy to Launch. Phillips Medisize is a part of Molex. We have opened a new Global Innovation and Development center in Bangalore, India and expected to grow in the Asian region.
At Koch companies, we are entrepreneurs. This means we openly challenge the status quo, find new ways to create value and get rewarded for our individual contributions. Any compensation range provided for a role is an estimate determined by available market data. The actual amount may be higher or lower than the range provided considering each candidate's knowledge, skills, abilities, and geographic location. If you have questions, please speak to your recruiter about the flexibility and detail of our compensation philosophy.
Who We Are
At Koch, employees are empowered to do what they do best to make life better. Learn how our business philosophy helps employees unleash their potential while creating value for themselves and the company.
Additionally, everyone has individual work and personal needs. We seek to enable the best work environment that helps you and the business work together to produce superior results.
