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The primary role of Engineering function is to apply advance skills and knowledge of manufacturing engineering discipline to develop and implement manufacturing processes, equipment, facilities and documents, in order to meet the current and future production volume, quality, OHS and cost requirements. Key deliverables include conducting prototyping and verification activities to determine the feasibility/suitability of a design. Assists in the development, execution, and testing of new and existing products.
Job Responsibility:
Lead and develop capabilities in NPI Manufacturing
Develop, innovate, and improve manufacturing processes and ensure the resultant processes are validated and compliant with our regulatory and GMP requirements and meet production volumes
Resolving technical issues and focusing on following OH&S guidelines
Introducing & maintaining production procedures, providing training on new equipment, processes & procedures
Complete process validation activities & documentation
Identification & implementation of quality and efficiency measures including GMP, Six-Sigma LEAN improvement actions
Budget for and manage resources required to support new process development and introduction activities across motor platforms
Develop and direct engineering resources allocated to new process development and introduction
Coaches team members on performance, provide inputs for performance evaluations and might be involved in pay actions
Represents Manufacturing whilst working closely with Product Development to ensure robust, manufacturable products
Frequently interacts with subordinates, stakeholders, and/or functional peer group managers, normally involving matters between functional areas or other company divisions or units
Often must lead a cooperative effort among members of a project team
Focuses on the development and implementation of strategic and operational objectives that help achieve organizational mission
Implements organization strategies through the effective direction and management of employees and resources
Ensure that appropriate measures are in place to protect intellectual property and ensure compliance with quality standards, regulatory and other business systems
Requirements:
Degree qualifications in a relevant discipline such as Engineering or Business management
At least 8 years relevant manufacturing experience, including experience in a similarly regulated industry
Experience leading engineering teams
Knowledge and experience of relevant business management systems (Microsoft and other software systems, GMP, Lean, 5S and Six Sigma methodologies)
Experience in high volume manufacturing
Experience with process qualification and validation within a regulated Quality System environment
Knowledge and experience in the application of SPC and related statistical techniques
Strong leadership and people development skills
Strong communication skills including the ability to present in large groups
Able to collaborate with stakeholder to align on strategy and desired outcomes
Keen sense of business acumen
Aligning team planning and decision making with the company goals
Team management with respect to personal development, scheduling, costing and design performance
Ability to negotiate competing project and company requirements, aligning team planning and decision making with the broader organization
Proficiency in MS Word, Excel and PowerPoint
Nice to have:
Engineering degree with post grad qualification
Medical device industry experience
Training in project management, experiment methodology, Six Sigma, DFSS, or other related engineering topics
Experience with continuous improvement, maintaining Configuration control, line balancing, and Kanban practices
Extensive knowledge of manufacturing processes & equipment for high volume production of discrete products
Equivalent combination of experience and/or education may be considered
What we offer:
comprehensive medical, vision, dental, and life, AD&D, short-term and long-term disability insurance, sleep care management, Health Savings Account (HSA), Flexible Spending Account (FSA), commuter benefits, 401(k), Employee Stock Purchase Plan (ESPP), Employee Assistance Program (EAP), and tuition assistance
Employees accrue three weeks Paid Time Off (PTO) in their first year of employment, receive 11 paid holidays plus 3 floating days and are eligible for 14 weeks of primary caregiver or two weeks of secondary caregiver leave when welcoming new family members
eligible to receive an annual cash bonus payment based on company, business unit, and/or individual performance