Senior Manufacturing Engineer

The Senior Manufacturing Engineer supports Interventional Urology implantable manufacturing by developing and implementing manufacturing procedures, methods, and processes that will maximize labor, material, and equipment utilization while meeting regulatory requirements.

Responsibilities

Supports Interventional Urology implantable manufacturing by developing and implementing manufacturing procedures, methods, and processes that maximize labor, material, and equipment utilization while meeting regulatory requirements; Identify and justify opportunities for implementing equipment upgrades, process improvements, and continuous improvement activities and initiatives (i.e. improving yield and reducing cycle time); Perform equipment, process and product performance qualifications and validations (including risk assessments); Lead effort to scale and stabilize manufacturing processes; Perform statistical analysis and report results in a technical protocol/report conforming to FDA standards; Serve as technical expert and conduct root cause analyses to provide resolution on manufacturing issues; Manage projects (including capital expenditures) to schedule and within budget; Perform all necessary functions from the purchasing, installation, and check out of new equipment; Plan, implement and document designed experiments to support equipment upgrades and process improvements; Responsible for GMP compliance of manufacturing equipment/processes; Support maintenance activities via utilization of engineering and technical knowledge / skill set; Document new and existing procedures as they relate to the manufacturing process; Conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the Advamed Code of Ethics on Interactions with Healthcare Professionals, and company policies; Perform other duties as assigned; Seek environmental, health and safety opportunities and make appropriate recommendations; Comply with corporate standards for environment, health, and safety; Reduce impacts on environment, health, and safety by systematically optimizing daily operations

Requirements

4-year engineering degree; 5+ years of related manufacturing work experience; Self-motivated and self-managed within a dynamic and collaborative team environment; Strong analytical and problem-solving skills, including the use of statistical analysis and continuous improvement methodologies / best practices; High performing individual that is able to accept challenges and opportunities as they arise; History of successful project management; Excellent written & oral communication skills; Advanced computer skills – Microsoft Office Suite (Access, Word, Excel, PowerPoint), Minitab, SolidWorks, etc.; Knowledge and capabilities in fabrication and design of mechanical parts, tools and assemblies; Knowledge of design for manufacturing (DFM) methodologies; Proficient decision-making skills; Proficient problem solving and trouble shooting skills; Ability to effectively interact with various internal and external customers/vendors; Ability to convey a positive and professional image to internal and external customers; Ability to apply multi disciplined problem-solving approaches to production and quality problems; Ability to exercise sound judgment to resolve manufacturing issues; Ability to work independently and with team members; Ability to multi-task and prioritize multiple projects; Ability to work in a fast pace dynamic environment; Ability to communicate and train cross functionally at every level of the business

Benefits

Comprehensive medical, dental, and vision insurance plans; Company sponsored wellness programs and mental health resources; Paid leave of absence for qualifying events; Generous paid parental leave for both birthing and non-birthing parents; Competitive 401(k) plan with company match that vests immediately; Financial planning services; Corporate discount programs for goods and services; Generous paid time off; Flexible work hours and flexible work arrangement options; Training programs, mentorship, and tuition reimbursement; Recognition programs, bonuses, awards, and special events; Team-building activities, volunteer opportunities, and company-sponsored events; Supportive work environment with a sense of belonging