R&D Assistant Manager

1.        Guide, direct & coordinate between the Development Engineers and project team on related R&D Projects towards manufacturing transfer of designs.
2.        Initialize & monitor personnel training program for R&D Engineers with primary focus on Engineer’s exposure to clinical procedures and help establish / maintain effective communication links and networking with established medical institutions
3.        Assist in the review, update & training with regard to the maintenance of the Design Control Procedures.
4.        Functions in a proactive role in research or development activities in the advance level scope of 
assignments, including studies & projects requiring analysis, extensive research associated with the design & design modification of medical devices, components & formulations.
5.        Functions also in other qualified capacities as a primary engineering resource on material, special project, process improvements and six sigma initiatives when required.
6.        Serves as project leader or guides the Development Engineers for the development of the project plan with critical milestones & timeline and with the responsibility to follow up on all aspects of projects  including review with support groups and outside resources where applicable.
7.        Develops & coordinates the running protocol for the validation of new or modified devices or components including validations of designs, manufacturing, assembly, packaging and sterilization where applicable with Development Engineers and the appropriate support group departments such as engineering, regulatory, documentation, tooling and manufacturing. 
8.        Works with manufacturing in the justification and the selection of the manufacturing process and assigns projects and establish priorities to ensure datelines and goals are achieved.
9.        Interface with process engineering & quality engineering to coordinate changes in process, tooling, equipment and material identified to positively impact the manufacturing process while staying within the regulatory requirements and Product Design Control procedures. 
10.        To ensure implementation and maintenance within the workplace of an effective management for occupational safety and health consistent with the Occupational Safety and Health Act 1994 and other legislative requirements.
 

Degree in a related engineering/polymer engineering/material science field, graduate or advanced degrees strongly preferred.

• 5-7 years proven development experience, ideally with 5 years in the Medical device industry and proven track record in innovative product design, development and implementation. Experience in regulating environment preferred.
• Strong skills in project planning and people management:
  • Actively develop a mentor associate. Provide frequent feedback and be accountable for their success.
  • Build a team with world-class expertise in product development
  • Develop a product development organization that has advanced understanding of external and internal customers to effectively to improve design and quality products.  
•  Must have strong organizational leadership, interpersonal and influencing skills. 
• Excellent verbal and written communication skills, detail orientation and analytical/problem solving skills are a must. Must be a highly motivated self-starter with the ability to achieve results with minimal direction. Confident to work with different levels of professionals and flexible approaches to problems.
• Integrity and trust -- unwavering commitment to "doing the right thing"