<p>Responsibilities</p> <ul> <li>Develop robust test methods and design test fixtures to ensure selected materials and prototype designs are accurately evaluated against specifications. </li><li>Own verification and validation activities through regulatory clearance and design transfer. </li><li>Manage multiple projects, maintaining schedules while serving as the primary point of contact for management. </li><li>Drive design reviews and ensure on-time completion of design control deliverables. </li><li>Design, assemble, and evaluate prototype device assemblies to assess technical feasibility. </li><li>Possibly manage direct reports, reinforcing open-door policies, and ensuring roles and expectations are clear. </li><li>Identify systemic department and organizational improvements, as well as product portfolio expansion opportunities. </li><li>Interface professionally with physicians and medical personnel, maintaining confidentiality and intellectual property vigilance. </li><li>Contribute to the design and development of product line extensions and improvements. </li><li>Author protocols and reports, including engineering studies using basic statistical methods. </li><li>Communicate with outside suppliers for component sourcing and refinement. </li></ul> <p>Essential Skills</p> <ul> <li>7+ years of experience in Medical Device (Catheter) and Project Management. </li><li>Proficiency in ISO13485, Mechanical Engineering, Mechanical Design, and New Product Development. </li><li>Expertise in Research & Development, Process Development, Process Improvement, and ISO standards. </li><li>Bachelor's Degree in Engineering or related technical field. </li><li>Demonstrated computer skills, preferably Solidworks, spreadsheets, word processing, databases, and other software. </li><li>Working knowledge of lab equipment such as calipers, micrometers, tensile testers, pressure testers, and vision measurement systems. </li></ul> <p>Additional Skills & Qualifications</p> <ul> <li>Advanced knowledge of materials and processes for medical devices, including extrusion, injection molding, and various fabrication techniques. </li><li>Expertise in generating new product designs, concepts, catheter materials, processes, and design plus test methods and metrology. </li><li>Experience in project management, documentation, design control methodology, and quality systems. </li><li>Ability to translate clinical needs into product requirements and detailed design specifications. </li><li>Substantial experience leading product development from ideation to commercialization. </li><li>Ability to supervise technical personnel and lead product development activities to completion. </li><li>CAD design expertise using Solidworks. </li></ul> <p>Pay and Benefits</p> <p>The pay range for this position is $130000.00 - $150000.00/yr.</p> <p>Health & Wellness:</p> <ul> <li>Employer-subsidized health insurance. </li><li>Employer-paid dental insurance. </li><li>Employer HSA contribution. </li><li>Gym membership subsidy. </li></ul> <p>Financial Security:</p> <ul> <li>401k plan with company match. </li><li>Employee Short Term Disability, Long Term Disability, and AD&D Life Insurance. </li></ul> <p>Time Off & Flexibility:</p> <ul> <li>9 paid holidays (including your birthday!). </li><li>PTO and Personal days. </li></ul> <p>Workplace Type</p> <p>This is a fully onsite position in Maple Grove,MN.</p> <p>Application Deadline</p> <p>This position is anticipated to close on Aug 29, 2025.</p> <p>About Actalent</p> <p>Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.</p> <p>The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.</p> <p>If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.</p>