Synergy Solutions

About Synergy Solutions

2 Principal R&D/Mechanical Engineers to assist in preparing product for EUMDR submission. Provide engineering expertise in support of EUMDR gap analysis, help to develop action plan, execute actions and deliverables, to ensure successful EUMDR approval. Position 1: - R&D /Mechanical w/ focus on Creating, developing, & remediating and validating test methods. Position 2 – Mechanical /R&D Background EUMDR Position Responsibilities: Works in conjunction with Project Manager, R&D, Design Assurance Engineers, Quality, Regulatory, and others functions to assist engineering team in identification, planning, execution, implementation, and monitoring of EUMDR preparation activities. Coordinate resources, from various departments, to resolve issues and implement changes. Provide Quality individual contribution and leadership for drawings and specifications improvements for existing products. Lead and/or participate in changes to product specifications, the product design, and/or manufacturing specifications/processes as appropriate to support manufacturing and quality objectives. Creates, develops, remediates and validates test methods. Creates and evaluates test protocols and reports to ensure that the validation testing is sufficient to meet regulatory requirements and department objectives. Designs and install quality process sampling systems, procedures, and statistical techniques. Interface with external suppliers including management of supplier corrective actions or to implement supplier changes as appropriate. Provide tactical process improvement and change management support to internal processes and external suppliers in resolving quality, productivity, and routine technical issues related to existing products. Promotes success through development of methods and arguments for achieving company objectives while adhering to Quality /Regulatory requirements and assures compliance to internal and external standards for product development and manufacturing. Perform qualifications to support changes to existing processes, components, and/or materials. Perform detailed Root Cause Investigation of failed product or processes using various quality tools (5 Whys, 6M, Ishikawa Diagram, Pareto Charts) Responsible for providing clear validation strategies and testing guidance for implementation of process changes that directly improve quality, cost, and supply of product. Develop and troubleshoot equipment and process issues. Summarize and draw conclusions from test results leading to effective technical resolution of process problems. Interfaces with Production, Manufacturing Engineering and Research and Development organizations to integrate new drawings, specifications or processes into the existing manufacturing site/areas. Plan and implement moderately complex projects to reduce manufacturing costs, improve processes, increase product quality and reliability, and enhance process capability. Disposition of Non-conforming material requiring advanced process/technical knowledge. Lead in resolving discrepancies between manufacturing and quality inspection criteria. Job Requirements: Bachelor's degree in engineering, science or equivalent (Mechanical, Biomedical, or Materials preferred) with 3-6 years of related work experience or 2-6 years with an applicable MS degree. Experience in medical device industry is required Ability to use personal computer and Windows-based software (Outlook, Word, Excel, PowerPoint preferred). Advanced knowledge of statistics, six sigma, and lean. Strong analytical and problem-solving skills. Experience in a regulated manufacturing environment - product and manufacturing processes. CT X-ray Medical Imaging experience. Job Type: Contract Salary: $50.00 to $70.00 /hour Full Time Opportunity: Yes Work Location: One location Schedule: Monday to Friday No weekends Day shift 8 hour shift

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Company Info

Legal Form: GmbH

Company Type: Private

Company Size: 11 - 50

Revenue: 25 - 100 million (USD)

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Job Ads found: 91

Job Ads per Month: 2.9

Hiring Locations: 11

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