Job Details: Manufacturing Systems Engineer - Capital Equipment
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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. xivgfpx
Excellent communication skills and ability to tailor messaging to technical and non‐technical audiences.