Apply Now Job ID R-333397 Date posted 03/21/2019 Job Description SummaryThis position is responsible for new product development and improvement along with managing projects with divisional impact. Manages new product development projects using project management principles, supports engineering test method development and validations. Designs, develops and implements new products, processes, test methods and equipment. Job Description
- Develops Innovative ideas for the organization.
- Broad business and technical understanding.
- Influences and directs others across organization; Coach/Mentor.
- Critical Decision Maker in areas of engineering and business needs.
- Initiates new or revised documentation and tracks through appropriate approval cycles and implementation.
- Maintains a professional working relationship with internal & external customer and support staff.
- Participates and leads cross-functional teams and/or projects.
- Provides technical support on components, material methods, systems, processes and/or equipment.
- Develops chemical, physical and functional test requirements to assure specifications & regulations are met.
- Writes and approves protocols, reports and data.
- Manages testing outlined in protocols and test methods.
- Manages/develops validation studies on equipment & processes.
- Understands and follows company procedures and regulatory requirements.
- Participates in and provides input to training on department & division procedures, and policies.
- Manages project planning, budgeting, scheduling and tracking.
- Analyzes problems in design, process, and/or test development. Recommend/implement solutions.
- Prepares and presents oral and written project updates and technical discussions.
- Develops and implements procedures/policy.
- Participates in collection of design input data.
- Responsible for development efforts for new products supplied by outside contractor/ partner.
- Participates in the design of new products and processes.
- Develops design verification and validation studies.
- Executes validation studies on equipment & processes for new products.
- Executes design controls.
- Responsible for project planning, budgeting, scheduling and tracking for new products.
- Develops and implements manufacturing procedures to provide production with easy to follow assembly instructions for new products.
Knowledge and Skills
- Determine and communicate project deliverables.
- Develop a work breakdown structure and estimates.
- Develop a viable schedule, management plans, and schedule.
- Execute and control the project through closure.
- Specific specialized engineering skills such as:
- Create & critique engineering cost analysis.
- Basic tooling design and drafting knowledge, as applicable.
- Analyze and optimize existing process and ability to create new processes.
- Create, analyze and optimize relevant manufacturing and quality systems.
- Product design and prototyping
- Ability to apply comparative statistics, as required.
- Software application skills.
- Ability to generate engineering proposals.
- Oral and written presentation skills.
- Comprehensive understanding of regulatory environment.
- Demonstrated ability to create and execute project plans;
- Advanced multi-project management skills.
- Ability to create and control a budget.
- Diverse technical background.
- Master Degree +3 years’ experience in medical devices or other regulated industry
- PhD +0 years’ experience
- Demonstrated knowledge of engineering principles through engineering experience including three (3) years of proven and effective project management skills.
- Background in materials science and/or polymer engineering a plus
- Experience with analytical test methods such as HPLC, ICP, GPC and FTIR a plus
- Background development and execution of Design of Experiments (DOEs) a plus
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Executive / senior industry position
Salt Lake City , United States