Plan, direct and implement all aspects of the company’s design and development of new and existing Invitro diagnostic instruments, reagents and consumable products. Oversee the investigation and evaluation of existing technologies. Guide the conceptualization of new methodologies, materials, machines, processes or products.
ESSENT IAL DUTIES AND RESPONSIBILITIES:
Direct the development of new product engineering concepts from initial design to market release.
Manage design feasibility studies to determine if new products will be capable of functioning as intended.
Monitor documentation maintenance throughout all phases of research and development.
Interpret requirements and apply engineering principles to develop robust and manufacturable designs.
Translate mechanical design solutions into manufacturable designs.
Create and interpret 2-D drawings.
Apply tolerance analysis techniques to ensure multi-component designs function across tolerance spreads.
Perform basic mechanical engineering calculations, conduct FEA and use empirical data to justify design solutions.
Identify and evaluate vendors to support product development.
Organize the coordination of activities with outside suppliers and consultants to ensure timely delivery.
Communicate and work with internal and external staff to facilitate the procurement of physical parts from specifications and drawings.
Generate and execute test plans to demonstrate designs meet requirements.
Manage projects utilizing project management software and tools.
Communicate, track, and report project progress.
Produce clear and succinct engineering reports, and presentations.
Generate design review content to effectively communicate results, hurdles, and design solutions to senior staff in peer design reviews.
Interpret engineering standards and regulations (ASME, ASTM, IPC, IEC, etc.)
Liaise with the customer and technical team to indentify needs and translate to product design.
Work with Quality Assurance and Regulatory Compliance adhering to all applicable FDA regulations and cGMP standards.
Direct activities of assigned group(s) to ensure optimum performance of the group/function.
Responsible for personnel management activities such as: scheduling, personnel actions (hiring, promotions, transfers, etc.), training and development, providing regular direction and feedback on performance, disciplinary actions and preparing and delivering annual performance and salary reviews.
Develop short- and long-range operating objectives, organizational structure, staffing requirements and succession plans.
Integrate activities with those of other major organizational units (e.g. segments, departments, functions).
Develop and recommend departmental budget and authorize expenditures.
Develop and oversee the implementation of departmental training programs, including orientation.
Support the policy of equal employment opportunity through affirmative action in personnel actions.
Ensure adherence to pertinent regulatory requirements and to departmental policies, practices and procedures [SOPs, safety procedures and biosafety protocols].
Perform all other related duties as assigned.
Education: Bachelor’s degree (B.S.) in electrical, mechanical or industrial engineering. Master’s degree a plus.
Experience: Minimum of 5years experience as an engineering/project managerinproduct development preferably in pharmaceutical or medical device industry.
An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
Other: Basic knowledge of material propertiesso data sheets can be interpreted and application specific materials are selected. Knowledge of manufacturing processes (i.e. milling, turning, bro a ching, wire EDM, injection m o lding, etc.). Understanding of software, circuit board design and imbedded coding components. Fundamental knowledge of Engineering Statistics and a basic understanding of electromechanical systems. Charles River Laboratories is an equal opportunity employer who values diversity in the workplace.
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