Title:  Senior Process Development Engineer

Job Summary

Reporting to the Process Development Manager, Global Engineering, this role will be part of the development engineering team within the Contract Manufacturing Operating Unit (CMOU) in West. This role will involve leading development projects in line with Commercial Ops new opportunities and drafting of the technical RFQs (Request for Quotation) within the global engineering functions.

Essential Duties and Responsibilities

• Lead the CMOU development activities for West customers through formal development activities and transition into a commercial launch, following established West product development policies (PDP) and Industry practices.
• Manage and work with external development partners, where required, who support the completion of development activities in West.
• Lead key activities within the Global Device Engineering Function specifically related to the quotation of commercial bids and development agreements.
• Support the creation of an environment that balances the necessary GMP compliance with the flexibility required for new product development.
• Works across business functions to align the Development activities to West’s and customers business objectives and needs.
• Work with internal stakeholders across global sites to understand customer & business needs and translate to technical outputs and costs.
• Identifying deliverables, time and cost, setting priorities, and reporting to meet the needs of the business and the customer.
• Demonstrate good leadership and communication with their team and with other organizations both internally and externally.
• Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.

Education

• Bachelor's degree or higher, in Electronic, Electrical, Mechanical, or Biomedical Engineering, or equivalent experience.

Work Experience

• Minimum 5 years’ of progressive experience in device development & manufacturing to support the manufacture of Medical Devices, risk management and mitigation, supplier performance management, quality engineering in the Medical Devices industry.

Preferred Knowledge, Skills and Abilities

• • Must have experience in dealing with customers and cross functional teams, internally and externally at all levels.
  • Have a good understanding of business development and the ability to interpret customer requirements.
  • Preferably be a technical leader and have demonstrated expertise in design, development, and validation process.
  • Preferably have experience in New Product Introductions working with moulding, assembly, packaging, and electronics
  • Preferably worked in either the medical, packaging, or technological industries with a good understanding of the regulatory requirements including working knowledge of ISO 13485; EU GMP, CFR Part 820.
  • Excellent written and verbal communication skills as well as the ability to accurately document work performed.
  • Ability to make independent and sound judgments based on facts.
  • Analytically minded with strong problem-solving skills.
  • Observe interpret and evaluate situations in a solution focused manner.
  • Learn and apply new information or new skills.
  • Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
  • Perform additional tasks at the discretion of the manager.

Travel Requirements

Physical Requirements