Boston Scientific Neuromodulation is the innovation leader in implantable pain management technology. Through its investments in technology, clinical science, and world-class service, Boston Scientific Neuromodulation is committed to Making life smoother™ for physicians and patients. For more information on SCS, visit www.ControlYourPain.com . Today, the Company is investigating a number of innovative bionic technologies to treat other neural disorders, including migraine headaches, depression, Parkinson’s tremors, urinary incontinence, and erectile dysfunction.
Process Development Department is seeking a Senior Process Development Engineer to work cross-functionally in a medical device manufacturing environment to lead process development of complex technologies on new products and ensure efficient and effective transfer of product into production. Develop solutions to a variety of complex problems of diverse scope (processes and equipment) and complexity where analysis of data requires evaluation of identifiable factors. Exercise authority and judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. The ideal candidate has broad knowledge of a variety of alternatives and their impact on the business unit, capable of managing multiple projects, working in a fast paced environment, and highly proficient technical writing and verbal, written communication and presentation skills.
Duties and Responsibilities
· Develop and implement process validation master reports, process failure modes and effect analysis, authoring protocols, executing protocols and writing final reports for process validations
· Lead cross-functional teams (Process Development, R&D, Manufacturing, Engineering, Production and Quality) to identify process development and validation strategies, critical process parameters, quality attributes and acceptance criteria.
· Characterize and perform design of experiments (DOE)
· Present strategies and data to cross-functional teams
· Interface with Development, Equipment and Manufacturing Engineering to coordinate the selection, procurement, installation and validation of equipment processes for new products
Specialized Knowledge and Skills
· Statistical analysis to perform design and experiments, process characterizations and validations
· Advanced technical writing and communication skills
· Working knowledge of medical device manufacturing requirements and FDA/ISO compliance guidelines
· Familiar with document release processes and expertise with advanced statistics, ability to analyze data, interpret results and write technical reports
· Bachelor’s Degree, Engineering
· Minimum 5 years of manufacturing engineering, advanced analytical and hands-on assembly equipment and processes experience
· Medical device industry experience focused on process characterization, process validation and working knowledge of validation methods, procedures and electro-mechanical equipment operation techniques
· Experience writing technical documents and reports
· Proficient in MS Office Word, Excel, Outlook
· Master’s Degree, Engineering
· Minimum 8 years’ experience in manufacturing engineering, product development or quality engineering
· Experience leading cross-functional teams from project inception to completion
· Electro-mechanical assembly, resistance/laser welding, curing processes, cleaning systems, bonding manufacturing methods, injection molding and automated assembly equipment experience
· Medical device industry technical writing experience
· Statistical software systems experience (Minitab highly preferred)
Boston Scientific knows that nothing is simple in matters of the heart. The company makes medical supplies and devices used to diagnose and...