Job Abstract

This position will work cross-functionally to lead Sustaining Engineering and/or Manufacturing Engineering group(s) ensuring capable and stable manufacturing processes reliable equipment performance, and managing post-release product changes relating to form, fit, function, or performance that relate to product requirements changes such as potentially affecting device usability, dimensional, material, or regulatory standards.  
The Sr Manager of Process and Sustaining Engineering may be responsible for Packaging Engineering activities in tandem with the sustain and manufacturing engineers’ responsibilities.  Packaging Engineering responsibilities will include managing pre and post release packaging and labeling activities, both during development and post-commercialization. This function will perform development, characterization, and verification and validation activities throughout the project and product lifecycle as it relates to packaging and labeling.
 

• Associate is responsible to follow requirements of applicable national and international regulations.
• Champion TMC’s equipment maintenance and process monitoring procedures and ensure compliance with cGMP.
• Work cross-functionally and provides the engineering discipline and strategic direction for team of Sustaining Engineers, Packaging engineers, Engineers, and Manufacturing Engineers to: 
  • Provide guidance and oversight of cross-functional activities in the conduct of root cause analyses of process non-conformances and implementation of corrective actions. 
  • Provide guidance and oversight for the daily operation and maintenance of production processes and related business continuity needs. 
  • Provide guidance and oversight for the identification, execution and implementation of performance and cost reduction continuous improvement opportunities for production processes.
  • Provide guidance and oversight for change management and engineering evaluation of product or process changes to maintain business continuity.
  • Provide guidance and accountability for packaging and labeling activities for products in development and post-commercialization. Accountable for developing technical SME expertise for both packaging and labeling.
• Partner with Marketing, Quality, and Operations to ensure our product families meet or exceed our customer needs, are produced with the highest quality, and are effectively manufactured.
• Plan work schedules, expenditures, attend meetings, and prepare monthly reports are required.
• Execute Talent Management Operating Cycle activities in accordance with the defined timelines for Talent Assessment, Performance Feedback, and Individual Development Plan (IDP) development and deployment.
• Will be responsible for projects which require coordination with other department’s personnel for completion.
• Other duties and or projects can be assigned as needed.

• Excellent leadership skills in inspiring, driving, and executing results through others. Must demonstrate and model effective listening, written and verbal communications, sound logical judgment, and organizational skills, while at the same time creating in others both a sense of urgency and a commitment to excellence. 
• Substantial experience in the development of global Medical Devices in accordance with global regulatory and quality standards and requirements.
• Demonstrated understanding of the cross-functional interactions needed for the development and change management of products within medical device industry design control guidelines.
• Proven ability to collaborate cross functionally and lead In-house teams of contractors and or associates to ensure manufacturing processes are compliant and robust.
• Demonstrate knowledge of Characterization, Validation, and Manufacture of disposable medical products. Fully proficient at documenting processes, process validations, engineering studies, and test methods.
• Demonstrated ability to manage design changes and assess engineering V&V activities related to product, packaging, and labeling form, fit, function, and performance.
• Demonstrated ability to manage design changes and assess engineering V&V activities related to product, packaging, and labeling form, fit, function, and performance.
• Ability to monitor and trend complaints and manufacturing performance to identify potential failure modes and recommend preventative measures.
• Excellent communication skills both verbal and written is required.
• SME understanding of design, verification and validation (V&V) approaches, packaging, and/or labeling when needed
   

• BS in Mechanical, Biomedical, or similar engineering discipline from an accredited university or college with advanced degree in Engineering preferred. 
• 10 years of work experience with increasing responsibility in Product and Process Development in the medical device field 
• Experience managing teams for 5 years; including direct supervision, development planning, performance planning, and conducting Performance Reviews with associates.