Staff Engineer, Manufacturing Engineer

Staff Engineer – BD (Tissuemed Ltd)

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GIE - EDE Staff Engineer

This position is responsible for Assembly Design and Process Implementation across the Medical Segment business and is positioned to ensure that the company's component design, supply, cost, etc. are aligned to business expectations. This position provides expert engineering skill, judgement, and mentoring of other engineers. This role will oversee the planning, coordination and oversight in the development and implementation of assembly and packaging equipment and related activities as well as support new product development.

This role will establish and maintain strong technical relationships at external vendors.

• Responsible for the design of assembly and packaging equipment, responsible for user requirements specifications (URS) to ensure it meets specific manufacturing requirements.
• Provide cost input into CB-2.
• Manage the integration of new equipment through SAT completion, and support Equipment Integration during install 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.
• Lead suppliers and external design teams (vendor) for larger capital projects to manage cost, lead time and scope.
• Partner with procurement for vendor selection.
• Actively participate with suppliers regarding process optimizations and continuous improvements on automation projects.
• Capture process performance from sites, existing assembly lines.
• 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 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 design reviews, risk assessments, and continue to build FMEA.
• Collaborate with manufacturing teams to build and test prototypes of mechanical systems and components, gathering feedback, iterating on design as necessary.
• Perform engineering analyses/simulations (stress, strain, thermal, fluid dynamics) to validate and optimize design.
• Work closely with other engineering fields to ensure seamless integration of mechanical systems with other project components.
• Support operations during a production crisis.
• 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.

• Cost of production & OEE. Percentage of project completed on time, in scope, and to budget.
• Reliability Overall Equipment Effectiveness. Number of process failures experienced.

• Minimum Education:
  
  Bachelor’s Degree in Mechanical Engineering, Electrical Engineering or related field.
• 5+ years in assembly equipment design / procurement.
• Tooling design experience of assembly processes is desired.
• Proficiency in Solid Works is desired.
• Excellent technical skills including project management, organization, planning, and capital budgets relating to equipment 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 40%.
• Experience leading projects end to end.
• Strong communication skills.
• Risk analysis / FMEA experience.
• Statistical analysis / SPC system experience.
• Ability to manage multiple conflicting…