This position is responsible for Assembly & Equipment Design and Process Implementation and is positioned to ensure that the company's equipment design, supply, cost, etc. are aligned to business expectations. This position provides expert engineering skill, judgement, and mentoring to engineers and team members. This role will oversee the specification, quoting, sourcing and build of equipment refurbishments as well as new equipment and lines to support the business needs.

RESPONSIBILITIES: 

Process & Equipment Development (Quality, Efficiency and Harmonization):

• Responsible for the generation of the user requirements specifications (URS) design (mechanical and/or electrical) and build of assembly and/or packaging equipment.

• Captures process performance from sites and create capital appropriation documents to support development of a capital request. 

• Manage the integration of new equipment through SAT completion, and support Equipment Integration during install, FAT and startup. Implement Process Design on new equipment and ensure product designs are being met.​

• Provide feedback and validate that the equipment design meets safety and operational standards based on experience and validation from respective stakeholders.

• Leads suppliers and external design teams (vendor) for larger capital projects to manage cost, lead time and scope.

• Partnerships with procurement for vendor selection.

• Responsible for vendor contracts in collaboration with procurement and legal​.

• Develop innovative concepts for mechanical systems and equipment based on project requirements, industry trends, and standard methodologies.

• Create, or obtain from the vendor, detailed 3D models/2D drawings of mechanical components and assemblies using CAD software.

• Create and maintain design documentation, including user requirement specifications, assembly instructions, bill of process, etc. ​

• Optimize equipment designs to minimize production costs and changeover time, simplify assembly processes, design from the operator’s standpoint, maintainability, and ensure manufacturability.​

• Participate in equipment design reviews, risk assessments, and continue to build failure mode and effects analysis (FMEA) to ensure reliability, safety, performance of mechanical systems/equipment.​

• Collaborates with manufacturing teams to build and test prototypes of mechanical systems and components, gathering feedback, iterating on design as necessary.

• Perform various engineering analyses / simulation (i.e. stress, strain, thermal, fluid dynamics) to validate and optimize design.

• Work closely with other engineering fields and Maintenance teams. (i.e. electrical/mechanical engineers) to ensure seamless integration of mechanical systems with other project components.

• Comply with all local, state, federal, and BD safety regulations, policies, and procedures.

• Comply with all local BD quality policies, procedures, and practices through consistent application of sound quality assurance principles.

• Other duties as assigned.

Minimum Experience:

• Works under general direction. Independently determines and develops approach to solutions.

• Tooling design experience of complex mechanical systems is desired

• Experience with PLC programming and Controls

• Proficiency in Autocad and/or SolidWorks is desired

• Excellent technical skills including project management, organization, planning, and capital budgets relating to mold procurement and verification.

• Demonstrated ability to apply problem solving and data analysis methods.

• Previous experience with Good Manufacturing Practice (GMP), ISO standards and Lean Manufacturing concepts desired.

• Experience in an FDA regulated quality environment desired.

• Willingness and ability to travel domestically and internationally up to 25% average annually.

• Experience leading projects end to end.

• Strong communication skills

• Risk analysis / FMEA

• Statistical analysis / SPC system

• Ability to manage multiple conflicting priorities, and to develop and maintain tool qualification schedules.

Physical requirement:

• Ability to use a laptop/computer for extended periods of time (up to 8 hours)

• Ability to sit for long periods of time (up to 8 hours) in virtual and/or on-site meetings

• Ability to stand for long periods of time (up to 8 hours) when conducting FAT, SAT, on-site equipment/process troubleshooting, etc.

• Ability to climb steps, squat, etc.

• Ability to work independently in High Volume manufacturing floor

• Follow Safety and Quality/GMP requirements for medical device manufacturing site (Safety shoes, safety glasses, hair net, beard net, face mask, hard hat, etc….as required per manufacturing site)