Job Summary
SUMMARY: Self-motivated and creative individual who will undertake technical project responsibility associated with manufacturing operations. Assumes a comprehensive role working and coordinating with, engineers, technicians and marketing personnel in a matrix organization. Candidate should have the requisite experience and skills to technically interact with fellow staff members along with vendors, consultants and contractors. Must be proficient in dividing the effort into a series of interdependent tasks that can be scheduled and tracked until completion. Supports all aspects of a regulated environment, e.g. Federal Food and Drug Administration (FDA), CE, ISO, UL, etc.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Support efforts to coordinate with internal and external stakeholders to assist in establishing and defining design projects, prioritization and execution.
Schedules projects by breaking them up into interdependent tasks that can be organized and tracked using software applications such as MS Project.
Supports design and development efforts from initial functional specification to manufacturing transfer. Quantitatively track the progress of design and development efforts relative to schedule and budgetary constraints.
Effectively interfaces with all members of the group in response to solving design and technical problems. You must possess a sufficient interdisciplinary technical background such that he/she can communicate effectively with support staff to drive effective solutions. Individuals should be capable of understanding pharmaceutical, medical device, aseptic techniques and associated unit operations.
Under Technical Operations supervision, writes specifications, design documentation and validation/verification requirements in support of FDA/ISO Design Control requirements.
Assists manufacturing transfer effort at the end of the design cycle. This includes technical support for vendors who provide a multitude of services such as plastic molding, machining, assembly, contract manufacturing, finishing etc.
Assures all regulatory compliance issues are being followed in the department's activities, e.g. cGMPs, ISO, SOX and Corporate Ethics policy.
Leads or participates on project teams chartered to achieve goals and objectives in support of new product, process or development.
Other activities may be assigned as required by management.
CORE COMPETENCIES:
Excellent written and verbal communications skills.
Knowledge of mechanical design processes. Must be capable of overseeing mechanical design efforts to make sure that designs met requirements (performance, structural, thermal, functional, aesthetics/finish etc.)
Knowledge of materials selection (polymeric) and associated processing methods for medical consumable designs. Must possess a working knowledge of associated packaging methods, biocompatibility requirements and where applicable, sterilization methods.
Understanding of electronics design for electro-mechanical instrument control systems. Some familiarity with microprocessor/mico controller technology, or OEM embedded processing module technology. Working understanding of the application of OEM sensors such as temperature, pressure, position, force etc.
EDUCATION and EXPERIENCE:
Bachelor of Science Degree in Engineering in associated technical discipline or business required
Three years of relevant work experience in the pharmaceutical/medical device industry
Experience with design, verification and validation testing for consumable and electro-medical devices.
Experience with medical infusion devices, catheters, endoscopy equipment and laparoscopic equipment a strong plus
Experience with Project Management tools and Budget Management tools. Understanding of FDA/ISO quality system requirements in both the design and manufacturing environments for medical devices
Computer Experience: MS Office. Experience with windows based database, CAD, CAM or programming environments a plus.
WORK ENVIRONMENT: The position is a home office based.
