Can you please confirm your top 3 skills sets required? Understanding of CAD/drawings/models, experience using DFMECA/PFMECA/DOEs, experience using problem solving techniques (A3s, DMAIC, 5 Whys, Fishbone, etc.). We would also prefer someone with medical device experience and strong collaboration skills as this role will be partnering with our Grand Rapids site. Can you please confirm the 3 main responsibilities/day to day activities required for this role? This role will support the integration activities for the newly acquired Grand Rapids, MI site (role will sit in Brooklyn Park). They have a lot of new equipment coming in, so we will need someone to collaborate on and approve validation work to ensure all design needs are met. There will also likely be component specification remediation work; there are instances where manufacturing can't use some components because the drawing specifications aren't manufacturable, so we will need someone to ensure changes don't impact the final product design. This would also include updating CAD models and drawings where applicable. This person would also be the day to day R&D support engineer, so could get pulled into issues that arise in production/quality. What products (if any) will this role support? Cardiopulmonary Cannula portfolio What is your target years of experience? 7+ The focus of this role is general sustaining activities in support of integration activities and programmatic savings projects at the Grand Rapids (GR) facility, impacting the Cardiopulmonary Cannula portfolio. Responsibilities will include assessing the impact of GR program-driven changes on product design and performance and supporting DHF remediation activities resulting from issues uncovered during the integration.
The candidate must be able to work with local subject matter experts to provide design input to Operations and Quality partners at the Grand Rapids site, and additionally to author detailed protocols, reports, and specifications, conduct design reviews, drive updates to test methods, and engage and direct CAD resources on print updates. Review and approval of Agile documentation and collaborating with cross-functional partners in operations.
Candidates must be willing to work in a fast-paced, multi-tasking, team environment.
A DAY IN THE LIFE
Develop and evaluate designs that meet defined product requirements and that are optimized for producibility, reliability, and overall cost to the business. Work with cross-functional teams to review, assess, and implement design input for injection molded components. Ability to troubleshoot design issues, particularly understanding design controls processes, qualifying risk, and requirements flow down. Conduct or direct the evaluation of designs against defined product requirements and ensure optimization for producibility, reliability, and overall cost to the business. Document and support decisions using engineering analysis and data. Verify the functionality of product design by developing design test methodology and specifications to ensure product designs meet applicable performance requirements. Utilize project management and DRM methodologies and adhere to the applicable medical device FDA requirements for design and manufacturing, including ISO 13485:2003 medical device materials, related processes, and GMP (Good Manufacturing Practices). Utilize design development, analysis, and statistical tools, to include Pro/E, Minitab, and statistical methods, including DOE, SPC, Measurement System Analysis, Variable Gauge R&R, attribute agreement analysis, ANOVA, t-test, and regression analysis. Interface with suppliers, manufacturing facilities, and various internal groups to resolve design and manufacturability issues of new and existing products. Create and communicate limited-scope project plans, tasks, and deliverables, and manage time to meet project deadlines. Lead troubleshooting and problem-solving efforts related to development projects. Support decisions through thorough engineering analysis and data. Nice to Have: BS or MS in Mechanical Engineering or equivalent with 7+ years of progressive mechanical design experience in a regulated medical industry Understanding and experience in injection molding of medical devices, thermoplastic part design, product engineering, and testing Proven communication skills and ability to lead within a multi-functional team environment A demonstrated capacity for solving problems through creative designs Knowledge and experience using DFMECA FMEA, DOE. Knowledge and experience with statistical analysis (Minitab, ANOVA) Basic understanding of CAD system outputs/drawings/models. Knowledge of FDA and ISO 13485:2003 to manage medical device materials, related processes, and GMP (Good Manufacturing Practices); Experience utilizing problem-solving techniques, including A3 thinking, PDCA (Plan, Do, Check, Act), 5 Why's, and Ishikawa (Fishbone).2 years of mechanical design experience in a regulated medical industry
