About SHL Medical

SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for patients. Headquartered in Switzerland since 2018, with key operations in Sweden, Taiwan, and the US, we are united by a commitment to innovation, impact, and growth. Together, we empower our people to develop solutions that make a meaningful difference in the lives of millions of patients while fostering a supportive, inclusive, and dynamic workplace for our colleagues.

Job Overview

• Create/embody patentable concepts for device innovation
• Manage, coordinate and perform product design engineering related activities in product development process, and ensure the product performance fulfilling the defined functional and safety requirement
• Execute the maintenance, support, and enhancement of product designs post-development, ensuring functionality, quality, and continuous enhancement to meet customer needs while maintaining high performance and reliability.  

Main Responsibilities

• Develop new concepts for devices in the innovation (BPG0020-Global Innovation Process Guideline).
• Coordinate and/or execute product design assessments related to business inquiries, e.g. initial business discussion, project intake process.
• Coordinate and executing tasks in compliance with product development process (S-000000774_Design Control, W-000000769_Design WI), including but not limited to the following:
  • In Planning phase
    1. manage and coordinating the feasibility evaluation of combination product containing SHL devices and customer PFS,
    2. Review the adequacy of design input requirements and alignment with functional and performance characteristics of the device.
    3. Establish the initiative documents for design input, including syringe/cartridge specification (PPS) and identification of product characteristics related to safety and associated hazards (Hazard Identification checklist, D-FMEA draft).
  • In Design phase
    1. Establish functional analysis documents (function description, assembly description, sub-system requirements), perform risk management analysis (HIC & DFMEA), syringe performance assessment (PPC protocol and report) and execute design analysis (planning, protocol & reporting) by using design analysis methods (TA, simulation, and testing).
    2. Review usability related documentation (User Interface Specification, Handling Description, IFU)
    3. Establish the E-BOM initial form structure
    4. Establish product drawings (3D model, component/sub-assembly/final assembly/customer drawing) with confirmation of DFMA review.
    5. Identify Design Assessment / Design Verification Test Cases (MTM) and create Design Assessment Master Plan.
    6. Conduct design review (Preliminary Design and DRII) and prepare corresponding meeting minutes and following up the actions to be done.
  • In Engineering phase:
    1. Host the design verification readiness review meeting, prepare corresponding meeting minutes and following up the actions to be done before DV execution.
    2. Update DFMEA with DV activities data.
  • In Submission phase
    1. Responsible for providing the information required for the submission package.

• Coordinate and/or execute the tasks of the maintenance, support, and enhancement for the Design production support
  • Provide technical assistance and guidance to production team (Operation Excellence team) (G-000009514 Technical Assessment of Design Change)
  • Participate in NCMR & complaint investigations (S-000000028_CAPA procedure, W-000000223_CAPA WI)
  • Lead local RCA investigations for design-related causes (prior escalation to technology level)
  • Maintain product & risk management documentation/DHF up to date (customer product level) (S-000000028_CAPA procedure, W-000000223_CAPA WI)
  • Propose and assess design improvements for manufacturability, cost, and/or performance improvements to platform/technology team
• Execute tasks related to device design for the Design Lifecycle Management (S-000000014_DC procedure, W-000000076_DC WI, S-000000026_CC procedure, W-000000814_CC and TC WI)
• Carry out assignments from supervisors
• Coach junior engineers to develop design skills and understand the best design practice (orientation guidance)
• Be the Serve as a peer and design reviewer for early detection of design flaws of design engineering work (Prod. Dev. TWN_Peer Review Guidance_Final(1.0))
• Involve in the global workshop for to resolve complex issues resolving (BPG0020-Global Innovation Process Guideline).
• Lead a group to produce designs, project proposals, and execute them effectively.
• Coordinate continuous improvement of design, system and process of SHL.