Job Details: Manufacturing Systems Engineer - Capital Equipment
Key Responsibilities
- Lead international New Product Introduction (NPI) projects, providing technical and operational leadership.
- Provide systems engineering support for corporate and cross‐functional initiatives.
- Serve as a core Operations team member in new product development, partnering with Manufacturing, Supply Chain, Sourcing, and R&D to develop and execute robust industrialization plans.
- Introduce, implement, and validate new manufacturing technologies, including capital investment and capacity planning.
- Oversee design controls–related operations documentation (plans, protocols, reports, test methods, work instructions, PFMEAs, control plans) and contribute to global regulatory submissions.
- Act as the Voice of Operations throughout the design cycle by leading Design for Excellence (DfX) reviews and ensuring alignment with lean manufacturing principles prior to design freeze.
- Partner closely with R&D to ensure manufacturing infrastructure supports product design, project milestones, and business objectives.
- Conduct process studies to identify and implement improvements in quality, efficiency, and scalability.
- Support lifecycle management initiatives to optimise manufacturing performance across the product portfolio.
Qualifications
- Master's degree in Engineering (Electrical, Biomedical, Mechanical, or related discipline) with 3+ years of relevant experience, or an equivalent combination of education and experience.
- Experience in a highly regulated industry; medical device experience strongly preferred.
- Understanding of ISO 13485, ISO 14971, and FDA 21 CFR Part 820 (or comparable regulatory frameworks).
- Expertise in process design, development, and manufacturing systems implementation.
- Strong engineering problem‐solving and analytical skills, with the ability to make sound decisions based on data—even when incomplete.
- Knowledge of electrical wiring design and manufacturing, including connections and integration.
- Understanding of PCBA design, manufacturing, and testing.
- Experience managing electronics development (multiple ECAD platforms considered a plus).
- Hands‐on experience with prototyping, development, and acceptance testing.
- High‐level proficiency in mechanical design tools (SolidWorks and/or Solid Edge).
- Ability to assess and mitigate product and project risks.
- Demonstrated ability to influence cross‐functional and international stakeholders without direct authority.
- Excellent communication skills and ability to tailor messaging to technical and non‐technical audiences.
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