Senior Engineer, Mechanical

Company: ICU Medical
Location: Minneapolis
Posted on: May 28, 2023

Job Description:

*Job Title:*Senior Mechanical Engineer /Position is 100% onsite role in Plymouth MN/ *FLSA Status:*Exempt *Description * /The Senior Mechanical Engineeris responsible for understanding infusion pump functionality, lead projects in the design of mechanical parts, components, subassemblies and assemblies based on design inputs, and generate design outputs according to product development requirements utilizing CAD tools/. An engineer in this role will also plan and perform necessary laboratory testing associated with medical device product development. The Senior Mechanical Engineer role is a specific role within the broader Sustaining Engineering functions reporting into the Advanced Manufacturing Engineering and Operations. The incumbent is expected to develop and effectively administrates his/her portion of projects, resources, and role responsibilities. The incumbent is expected to communicate all necessary information to management to ensure proper decisions are being taken. The incumbent will routinely encounter conflicting priorities that need timely resolutions and will require constant revision to remain consistent with program objectives and customer delivery commitments. The incumbent is expected to execute tasks and projects as committed to by plan, schedule, or tasks assigned by supervisor. Essential Duties & Responsibilities * Provide technical expertise and timely implementation of all engineering designs, design changes and design documentation for On-Market products. * Develop project timelines, assign the appropriate resources, monitor progress of projects, and make the necessary adjustments to meet project commitments. * Interface directly with personnel at all levels of Technical Operations, Manufacturing, Quality, Regulatory Affairs, Program Management, Research and Development, Medical, Marketing and Materials Management. * Champion technical oversights and lead team in providing solutions for complex problems to CAPA investigations to properly identify root cause and corrective actions. * Provide technical support to manufacturing operation and vendor root cause investigations to ensure appropriate corrective actions have been identified. * Identify and implement programs to reduce costs, improve quality, and improve functionality of products. * Address manufacturing and end-of-life issues in a timely manner to avoid or minimize production issues. Knowledge, Skills & Qualifications * Experienced with FDA-regulated environments, ISO9001, ISO13485, 21CFR Part 11 & Part 820 and cGMP for medical devices industry. * Strong knowledge of product design and design control process associated with medical devices such as Infusion pumps. * Strong organizational skills and ability to collaborate effectively with both internal cross-functional teams and external contract manufacturers/suppliers. * 3D/2D CAD Modeling, Design Drafting and use or knowledge of Finite Element Analysis (FEA) tools. * Experienced in failure analysis (FMEA) and root cause identification resulting in product improvement. * Mechanical Tolerance Stack Analysis, Geometric Dimensions and Tolerances (GD&T) * Statistical Data Processing: Use of Statistical Tools (e.g., Minitab) to Analyze and Calculate Probabilities * Design of Experiments (DOE), Test Protocols, Laboratory Testing, Data Collection & Test Reports Education and Experience * Bachelor's degree in Engineeringfrom an accredited college or university is required. Master's degree is preferred. * Minimum 6 years of experience required. 8 years of experience is preferred. Medical Device industry experience is preferred. Travel Requirements * Typically requires travel less than 25% of the time. Local travel only. Physical Requirements and Work Environment * While performing the duties of this job, the employee is regularly required to talk or hear. This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. * Work is performed in a clean room environment. While performing the duties of this job, the employee may be required to sit or stand for long periods of time. Must be able to occasionally move and lift objects of up to 25 lbs. ICU Medical is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Title: Senior Engineer, Mechanical Location: MN-Plymouth Requisition ID: 23300105

Keywords: ICU Medical, Minneapolis , Senior Engineer, Mechanical, Engineering , Minneapolis, Minnesota