Sr Manufacturing Engineer - Exempt Job at LanceSoft in North Haven

JOB DESCRIPTIONFull time in office North Haven CTA Day in the LifeResponsibilities may include the following and other duties may be assigned.•Support in-service operating systems to ensure continued operation and maintenance and optimization throughout.•Determine, select and implement technically feasible and economically viable alternatives for sustainment.•Analyze and evaluate how to improve a system and/or equipment's sustainability under continued operation, maintenance and unexpected change.•Develop design changes to resolve operational issues, introduce new materials and revises product, process and test specifications to enhance product quality, design integrity, reliability and manufacturability.•Collect and evaluate service use and maintenance data; conduct root-cause analyses of in-service problems (e.g., operational hazards, deficiency reports, parts obsolescence, corrosion effects, reliability and maintainability trends, safety hazards, and failure causes and effects) and implement corrective action.Must Have: Minimum Requirement•Bachelors degree required•Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experienceNice to Have•Bachelor or Masters degree in engineering•FDA 21 CFR part 820, ISO 13485, ISO 14971 and GMP•Statistical analysis tools to include Minitab, DOE, process capability, measurement system and confidence interval analysis, Six Sigma•Process Verification & Validation, IQ/OQ/PQ and TMV•DFMEA, PFMEA, Process Mapping and Critical to Quality reviews•DFA/DFM, Design and manufacturing documentation to include specifications, procedures, sampling methods, tolerance studies and GD&T•CAPA, Root Cause investigations quality tools to include DMAIC A3, 5 Whys, 6 M, Ishikawa Diagram and Pareto Charts•Dynamic, positive attitude and Strong communication, manufacturing process, product industrialization and leadership, presentation skills•Experience in assembly equipment technologies, well versed in molding, stamping and machining methodsResponsibilities may include the following and other duties may be assigned. Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling. Designs arrangement of machines within plant facilities to ensure most efficient and productive layout. Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance. Adapts machine or equipment design to factory and production conditions. May incorporate inspection and test requirements into the production plan. Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality. Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques. Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques. Ensures processes and procedures are in compliance with regulations. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University). DIFFERENTIATING FACTORS Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes. Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments. Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements. Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decisionmaking. Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product . Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.