Mechanical Engineer Lead
Year Bengaluru, Karnataka, India
Job Description
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Your Job Phillips-Medisize, India is seeking a Senior Mechanical Design Engineer to design and develop medical device and drug delivery products, following the Phillips-Medisize Design Development Process (DDP) and applicable standards such as ISO 13485 with design controls, ISO 14971 and appropriate ASME standards. Our Team
- Operate primary CAD systems such as NX or SolidWorks or Creo
- Generate product designs that meet product requirements
- Identify and analyze design risks using tools such as tolerance analysis, static or dynamic simulation or hand calculations.
- Develop appropriate design risk mitigations and test strategies
- Work with production facilities to understand and incorporate production intent design for manufacturing (component level) and design for assembly (assembly level) into the design.
- Develop appropriate assembly and test fixtures to aid in the manufacture and testing of the design,
- Integrate the electronic elements into the product design
- Develop appropriate drawings to detail product and assembly specifications in a manner compliant with ASME or other design standards
- Maintain a design journal that identifies product risk and tracks design changes throughout the Design Development Process.
- Generate Database Approval Forms and Engineering Change Orders to document design changes and customer approval.
- Identify and assess Design Risk via a dFMEA
- Identify potential manufacturing risks within the design of the components and assembly.
- Use or coordinate appropriate analytical techniques such as Tolerance Analysis, MoldFlow, SWX Simulation, SWX Plastics or ANSYS to aide in the analysis of the design
- Ensure that design inputs and outputs are properly documented and controlled according to relevant procedures.
- Generate and control Drawings and Specifications according to relevant work instructions.
- Set up and Perform engineering test for component verification against mechanical specification.
- Design/selection of components used in drug delivery devices such as springs, elastomers, plastic parts, sheet metal components, Selection of material for plastic parts, elastomers that encounters drugs.
- Design of parts compliance to US pharmacopeia standards such as USP 87, US 88, USP 661, USP 381, ISO 10993.
- Generate free body diagrams considering intended use cases and unintended use cases.
- Design of mechanism with appropriate number of constraints. Perform kinematic evaluation of mechanism.
- Identify functions in a product that are essential to performance.
- Generate engineering test data and use statistical tools to analyze engineering test data.
- Determining safety factors for each mechanical specification considering uncertainty in loading conditions, material property variations, environmental factors, material ageing.
- Other duties as assigned.
- Familiar with ISO 13485 and ISO 14971
- Ability to generate complex solid models
- Familiar with various plastic materials and design limitations or potential design risks for said material
- Use of Minitab for statistical calculation and engineering decision making
- Use of strength analysis tools
- Strong written and verbal communication skills; ability to communicate design intent to a diverse audience
- Experienced understanding of injection mold operation
- Understanding of the behavior of plastics and other materials as they relate to mechanics, function, and creep
- 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
- Bachelor of Science in Mechanical Design or Engineering
- Minimum 7 years of experience in the design of mechanical or electro-mechanical drug / biologic delivery devices (pen injectors, auto-injectors and wearable pumps).
- Plastic injection molding and product development
- Design experience with medical devices or similar products
- Strong Design for Manufacturability experience focusing on plastic injection molding and plastic assembly methods (snaps, sonic welding, press fit, sealing, etc)
- Proven history of providing innovative design solutions
- Experience performing tolerance analysis and structural analysis
- A challenging position in an international innovative and successful company that is growing.
- An opportunity to setup the processes and development team in India to support the Indian customers.
- 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
- Salary on a competitive level.
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Job Detail
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Job IdJD3254021
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationBengaluru, Karnataka, India
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EducationNot mentioned
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ExperienceYear