The Sr. Engineer will be responsible for design controls management and input for sustaining production and derivative design project related changes, initiatives, projects, quality tasks, etc. The desired individual will possess a broad range of medical device production, quality, ERP, and design experience. Applies knowledge and expertise acquired through progressive experience to resolve crucial production/production system issues and/or unique conditions. Keeps informed of new methods and developments affecting their products. This position will work closely with members of the project core team (marketing, design, quality, and regulatory) as well as interface directly with customers & suppliers. The Sr. Manufacturing Engineer develops new technology, concepts, products or processes with minimal supervision. He/She independently, or as a member of a team, develops, directs, and executes plans for complex projects.
Essential Job Duties and Responsibilities
Lead a major New Product Introduction (NPI) project(s) or several moderate projects from concept through production. Prepare the project plan, schedule and budgets. Execute the project by coordinating activities, documenting project goals and progress and recommending appropriate changes when needed.
Demonstrates a complete understanding of the relationship between production changes and their impact on the DHF and can provide well-justified recommendations for modifications of DHF as a result of engineering changes during the production life of a product.
Mentor junior engineers, modeling and encouraging creativity, innovation, data driven decision making, and careful use of scientific methods.
Compile and analyze operational, test, and research data to establish technical specifications for designing or modifying products, processes, and materials.
Understands and addresses ERP structures/configurations that assist with cost control and appropriate quality tracking within the ERP system.
Successfully complete engineering work in one or more of the following: technology development, process and production controls, test of materials or products, preparation of specifications, process study and design verification/validation protocol/report preparation, process/equipment validation protocols.
Support production environment as the lead engineer assessing process and production floor changes against design, ERP, cost, and quality impacts.
Participate and lead validation reviews and provide guidance to improve processes to meet design requirements while considering design for manufacturing aspects.
Provide consultation on projects involving released products to improve quality, maintain supply, maintain regulatory or standards compliance, reduce costs or add functionality.
Design and coordinate engineering tests and experiments using techniques such as Design of Experiment (DOE).
Summarize, analyze, and draws conclusions from complex test results using valid statistical techniques.
Build Quality into all aspects of work by maintaining compliance to all quality requirements.
Lead and/or participate in the Risk Management process including Design, Process and Use Risk Assessments.
Prepare process/engineering documentation in support of Regulatory submissions.
Coordinate development activities to meet customer requirements where applicable.
Represent Nordson Medical as a senior technical lead in customer discussions.
Process validation and control for plastic injection molding and over-molding.
All other duties as assigned.
Education and Experience Requirements
Detail-oriented, energetic self-starter with strong communication and organizational skills. The successful candidate will have a proven ability to multi-task and work collaboratively as well as independently in a dynamic and entrepreneurial environment. Additional qualifications are as follows:
BS degree in Mechanical or Biomedical Engineering.
5+ years of related experience.
Technical project leadership experience.
Experience developing and supporting low to medium volume products in a fast-paced regulated environment to meet rigid quality requirements.
Understanding of design controls relating to medical device regulations and the principles of the EU Medical Device Directive (93/42/EEC) and Medical Device Regulation (2017/745), FDA GMP, ISO 13485, Health Canada and their fundamental requirements.
Ability to understand and work with medical device quality processes and statistics.
Experience with and training on SolidWorks.
Ability to be able to work in a team environment.
Excellent interpersonal, communication and strong attention to detail.
Preferred Skills and Abilities
Experience designing injection molded parts.
Competent in application of statistical analysis software.
Experience with SolidWorks Simulation and Enterprise PDM.
Working Conditions and Physical Demands
Office/Lab environment. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
