Job Posting TitleEngineer II, PackagingProvide solid technical skill and engineering support for design and development activities for new and existing products. Support current products in terms of quality, manufacturing, supply continuity and cost improvement. Participate in executing technical and/or cross-functional project work. Contribute to a culture of innovation by proactively generating Client concepts for new products and enhancements to current product performance. Understand customer needs through literature review, customer interviews, direct observation, competitive analysis, prototype evaluation, and clinical/simulated use studies. Translate customer needs into engineering requirements into specific product, packaging and process specifications. Engineer robust and manufactural products through strong understanding and application of engineering fundamentals. Develop and execute test methods which specify measurement equipment, test set-up, measurement systems analysis, and data analysis. Write detailed technical reports based on design verification analysis/testing for design changes and product design activities. Ensure compliance with Client quality policies, procedures and practices as well as with all local, state, federal and Client safety regulations, policies and procedures. BS degree in engineering is required (Mechanical or Biomedical Engineering preferred). 2-4 years of engineering experience is required, preferably in medical devices. Demonstrated ability to utilize statistical tools and computer analysis.Job Description updateMedical Device packaging engineer with knowledge and experience in regulated packaging industry. Minimum 2 years experience. Demonstrates working knowledge of package engineering principles and techniques Demonstrates working knowledge of legal requirements and documents Designs, prototypes and qualifies standard new packaging concepts in accordance with cGMP's with moderate guidance Evaluates and improves standard existing packaging concepts with moderate guidance Identifies, analyzes and specifies standard packaging materials and equipment with moderate guidance Supports external resource/contractors as required Has developed knowledge and skills in packaging; still acquiring / expanding fundamental knowledge and higher-level skills Applies knowledge and skills to a variety of standard activities Works with moderate guidance in own area of knowledge Collects basic information needed to analyze a problem, situation or issue Performs routine or basic analysis, following the correct steps and using the appropriate tools, observing and seeking guidance from senior staff when necessary Identifies basic implications/conclusions from the logical analysis of a routine situation or issue demonstrates basic understanding of functional goals and sound knowledge of technical areas within project scope; applies knowledge in developing basic solutions Serves as a credible resource to others; answers basic questions pertaining to a specific area of expertise Effectively communicates technical knowledge and validates understanding of others Packaging test methods/standards and related equipment, Medical device packaging system development for flexible and rigid packaging applications. Packaging system verification and validation experience Experience with statistics and design of experiments. Knowledge of the following standards: ISO 13485, ISO 11607, and ISO 14971.
Select Source International is a Global Solutions provider of IT staffing and Project services. Our service offering has 5 main practices; ERP, Application Development, Middleware, Database Management and Project Services. SSI offers industry leading Data Migration, Compliance, and Risk Management through its subsidiary Data Wave. Data Wave offers Cyber Security and risk management through a GRC product suite called Risk Utilities. In addition to our technology offerings, SSI also provides administrative and business consulting services. Industry Experience: Retail Healthcare Manufacturing Energy and Utilities Government Financial Engineering