Sr. Product Development Engineer

$90K - $110K
Posted on 10/20/17
Morrisville, NC
5 - 7 years experience
Medical Devices & Diagnostics
$90K - $110K
Posted on 10/20/17

Opportunity 

Under minimal direction, the Sr. Product Development Engineer is responsible for the development and maintenance of Anesthesia products; however assignments may include work for other products within the Teleflex portfolio. Experience and background requirements should focus on Disposable Anesthesia products. Incumbent organizes and manages multiple projects and insures projects are completed in a timely manner; creates design ideas for new products as well as creative solutions to existing products when problems arise or modifications are requested; and performs other related duties as required.

Division Information 

Teleflex partners with Anesthesia professionals to promote high quality healthcare. For over 100 years, our comprehensive range of clinician inspired products from Arrow, Rusch and Hudson RCI have advanced the art of anesthesia by improving safety, procedural efficiency, and patient satisfaction. Our commitment is to continue this legacy of innovation and quality by providing world-class products, clinical education and support.

Position Description 

Position Summary:

Under minimal direction, incumbent is responsible for the development and maintenance of Anesthesia products; however assignments may include work for other products within the Teleflex portfolio. Experience and background requirements should focus on Disposable Anesthesia products. Incumbent organizes and manages multiple projects and insures projects are completed in a timely manner; creates design ideas for new products as well as creative solutions to existing products when problems arise or modifications are requested; and performs other related duties as required.

Incumbent in this class performs the advance level scope of assignments to plan, design and coordinate the development and implementation of molds and related engineering activities to support new product development projects through manufacturing scale-up. Incumbent at this level receive only occasional instruction or assistance as new or unusual situations arise, and are fully aware of the operating procedures and policies of the work unit.

Principal Responsibilities:

•Conducts research or development projects associated with the design and design modifications of medical devices, components, models, or mechanisms. 

•Prepares or coordinates formal documentation of the product Designs, Risk Analysis, Product Specifications, Market Specifications, etc. according to established Product Development Procedures, and initiates formal reviews to get approved per said procedures.

•Develops, maintains and publishes product Development Plans for assigned projects with critical milestones and timelines.

•Develops and coordinates the running protocols for the validations of new or modified devices or components, including validations of the design, manufacturing process, assembly, packaging, and sterilization where applicable.

•Supports new product development and sustaining engineering efforts for the Manufacturing plants as applicable. Teleflex is a Global organization with manufacturing facilities in the US, Mexico, Czech Republic, Malaysia and Germany. Ability to travel in international locations in mandatory. 

•Investigates and resolves technical problems involving product performance, production equipment or facility systems affecting production.

•Coordinates the product design and development process with appropriate support departments such as engineering, regulatory, documentation, tooling and manufacturing.

•Serves as the project leader for assigned projects and responsible to follow up on all aspects of projects, including reviews with support groups and outside resources where applicable.

•Prepares or follows up on preparation of design drawings, specifications, estimates of costs, mainframe updates, etc.

•Supports Packaging and Kit generation for assigned products

•Discusses and consults with sales staff or customer on product requirements and specification 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.

•Develops assembly methods and procedures; creates engineering draws and specifications.

•Coordinates changes in process, tolling and equipment identified to positively impact the manufacturing process, while staying within Design Control guidelines.

•Coordinates the reporting on project status for all responsible projects and directs reports in formal periodic project review meetings, which include cost reduction, progress, and capital spending and expense status. 

•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.

MARGINAL FUNCTIONS

•Enhances growth and development through participation in education programs, current literature, training meetings and workshops.

•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 employee handbook and as specified in departmental policies and procedures.

Perform other related duties as assigned or requested.

Requirements 

Education/ExperienceRequired:

•Possession of Master of Science Degree in Engineering or closely related field; possession of Master of Science Degree may be substituted for six (6) additional years of work experience in the design of devices. Preferred in the anesthesia fields

•Experience in SolidWorks CADD (design/drafting) program

•Microsoft Office Suite, (Project, Word, Excel and Access) 

•Injection molding, plastic extrusion and plastic part assembly process and methods

•U.S. FDA GMP 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

•Principles and practices of professional engineering

•Regulations pertaining to medical device design and design modifications

SPECIALIZED SKILLS & OTHER REQUIREMENTS: 

Skill Sets:

•Effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

•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.

•Analyze complex, technical and administrative problems and adopt an effective course of action.

•Make effective presentations to, and participate in a variety of meetings and conferences with other companies 

Ability To:

•Demonstrate creativity and ingenuity in applying engineering principles and practices.

•Draw solutions form a wider range of experience.

•Organize, evaluate, and coordinate engineering studies with professional, technical, and clerical staff of a product evaluation department.

•Conduct comprehensive studies and preparation of reports including recommendations.

•Establish and maintain cooperative relationships with those contacted in the course of work.

•Prepare clear and concise statements and reports.

•Establish and maintain cooperative relations with those contracted in the workplace.

•Speak and write English fluently.

TRAVELREQUIRED: 20%

Company Information 

Teleflex is a global provider of specialty medical devices used for a range of procedures in critical care and surgery. We serve hospitals and clinicians in more than 130 countries with well known, trusted brands in vascular access, general and regional anesthesia, urology, respiratory care, cardiac care, and surgery. We also provide products and services for device manufacturers. Our products are designed to cost effectively provide clinical benefits and enable healthcare providers to improve outcomes and enhance patient and provider safety.

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