Manager, R&D Sustaining Engineering AEM

Position Summary

As part of the Anesthesia & Emergency Medicine Business Unit and in the Research & Development team, this position is responsible for all the Kulim R&D and Sustaining Engineering functions for the AEM BU. This position is responsible to manage new product development, design transfer, process development, as well sustaining changes within current Design Controls maintained by Teleflex policies and procedures. This position provides design-level support to operations projects which require R&D oversight. The position organizes and manages multiple projects to ensure timely completion, utilizing creative solutions when issues arise. The Manager of R&D Sustaining Engineering position includes direct management of Development, Sustaining, Process and/or Tooling Engineers, and the R&D Laboratory.  Position may also be responsible for individual project management. The incumbent must develop strong inter-departmental relationships. Ability to be an individual contributor, and act as technical lead if necessary while managing direct reports, project teams and R&D laboratory efforts effectively.

Principal Responsibilities

• Conducts research or development projects associated with the design and design modifications of medical devices, components, models, or mechanisms. 
• Ensures staff prepares or coordinates formal documentation of the product Designs, Risk Analysis, Product Specifications, User Needs, etc. according to established Design Control Procedures, and initiates formal reviews to get approved per procedures.
• Responsible for remediation and updates of Design History Files, Technical Files or other product registration efforts as required.
• Responsible to ensure Design History Files and Technical Files are current to current regulatory requirements.
• Ensures staff is trained to all current procedures and regulatory requirements required for successful performance of their positions.
• Develops, maintains and publishes product Development Plans for assigned projects with critical milestones and timelines.
• Coordinates the product design and development process with appropriate support departments such as engineering, quality, regulatory, documentation, global procurement, and manufacturing.
• Assigns project leaders for assigned projects and responsible to follow up on all aspects of projects, including reviews with support groups and outside resources where applicable.
• Ensures staff prepares or follows up on preparation of design drawings, specifications, estimates of costs, system updates, etc.
• Discusses and consults with sales, clinical, etc. on product requirements and specifications where design or manufacturing problems are involved.
• Works with manufacturing in the justification and the selection of the manufacturing process and assigns projects and establishes priorities to ensure datelines and goals are achieved.
• Coordinates the reporting on project status for all responsible projects and directs reports in formal periodic project review meetings, which include cost reduction, progress, capital spending and expense status. Reports via electronic systems as appropriate.
• Enhances growth and development through participation in education programs, professional development, industry conferences, current literature, training meetings and workshops.
• Mentor for junior level employees.
• Participates actively in continuous quality improvement activities through compliance with safety standards.
• Demonstrates professional responsibilities by cooperating with other personnel to achieve department objectives and maintain good employee relations, interdepartmental objectives, and departmental goals and objectives.
• Maintains compliance with principles of accepted employee conduct as identified in the Teleflex policies, procedures, and core values.
• Manage Development Engineers and Project Teams effectively.
• Demonstrate creativity and ingenuity in applying engineering principles and practices. Draw solutions form a wider range of experience. Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists; interprets a variety of instructions furnished in written, oral, diagram, or schedule form.
• Organize, evaluate, and coordinate engineering studies with professional, technical, and clerical staff of a product evaluation department. Analyze complex, technical, and administrative problems and adopt an effective course of action. Conduct comprehensive studies and preparation of reports including recommendations.
• Develop project and departmental budgets and schedules and provide regular reporting.
• Conduct Personnel Evaluations for direct reports, recommend employee actions.
• Performs other related duties as assigned or requested.

Education / Experience Requirements

• Possession of MS or BS degree in engineering or closely related field. Possession of specific degree may be substituted by equivalent work experience in the design and/or modification of plastic components for the medical industry.
• At least 5-7 years of progressive responsibility in leadership role and professional engineering experience in Medical Device Development, Plastic, Silicone part design experience is mandatory.
• CADD (design/drafting) program, to include SolidWorks Experience is added advantage.
• Proficient in the Microsoft Office Suite, (Project, Word, Excel, and PowerPoint).
• Plastic / LSR Injection molding, plastic extrusion and molded part assembly process and methods experience.
• Basic Lab principles and operation.
• U.S. FDA GMP, International Regulations and ISO requirements for the design, validation, manufacturing processes, secondary operations and assembly of medical components and devices. ISO and ASTM testing methods for medical devices and general plastic components.

Specialized Skills / Other Requirements

• Effectively present information and communicate with all levels including peers, managers, executive leadership, customers, while always Building Trust.
• Strong written and verbal communication skills; excellent attention to detail.
• Solve challenges and deal with a variety of concrete variables in situations where only limited standardization exists. High adaptability, self-motivated and a willingness to try new challenges.
• Analyze complex, technical, and administrative problems and adopt an effective course of action.
• Ability to:

- Form positive relationships which result in better project outcomes and make Teleflex a great place to work.
- Ability to travel domestically and internationally. Up to 15%
- Demonstrate creativity and ingenuity in applying project leadership, engineering principles and practices.
- Organize, evaluate, and coordinate engineering studies with professional, technical, and clerical staff of a product evaluation department.
- Establish and maintain cooperative relationships with those contacted in the course of work.
- Prepare clear and concise updates and reports.
- Speak and write English fluently.