Sr. Engineer, Manufacturing Position Summary The Sr. Manufacturing Engineer will develop and implement optimal, cost-effective manufacturing processes and methods in accordance with product specifications and quality standards. This role will also recommend and implement improvements to production processes, methods, and controls and coordinate manufacturing launch for new or revised products. This role wilk support daily management activities to ensure commitments are achieved and communicated to the customer support teams. Principle Responsibilities Develops and implements optimized, highly capable, and cost-effective manufacturing processes and inspection methods (as applicable), in accordance with product specifications and quality standards. Develops overall engineering project strategies and timelines, including critical path identification and project risks. Recommends and implements improvements to production processes, assembly methods, and controls by utilizing Lean Manufacturing and Six Sigma tools. Collaborates with other departments for product tooling, gauging and fixtures design to ensure production methods are robust in support to achieving zero defects, reducing cost of poor quality, and implementing standard work. Supports creation of PFMEAs, control plans, process flow documents, contact material documents, and other related manufacturing documentation. Estimates resource requirements, production times, and relative costs to provide data for operational decision-making. Provides design for manufacturing (DFM) feedback for all products, both new and sustaining. Leads justification memos and reports for capital expenditures. Participates in the engineering change notice process and contract review process for the engineering team to ensure timely release of engineering changes and customer orders. Utilizes SolidWorks, NX, or other 3D Modeling software to create and/or modify process drawings. Works closely with cross-functional departments to develop, coordinate, and implement technical training for employees. Provides engineering support to the production department to troubleshoot and resolve technical problems Leads IQ/OQ/PQ and other process validations activities, including overall strategies and timelines. Provides support for CNC programming activities. Further develop and refine Engineering departmental standards and best practices. Provides basic guidance, mentoring, and training to engineering staff. Supports organization and site policies and procedures, goals and objectives, applicable regulations, and good manufacturing practices. As applicable, read, analyze, and interpret general business periodicals, professional journals, technical procedures, industry standards and governmental regulations. Addresses customers' issues and improves performance, appearance, and impact of product on the end-user. Provides support to manufacturing, marketing, and customer service, interfaces with customers and suppliers. Applies critical thinking skills to solve practical problems that incorporate a variety of inputs in multi-variable scenarios. Performs other duties or special projects as required or as assigned by supervisor

Qualification Requirements Credentials/Experience:

Bachelor's degree in engineering (biomedical engineering, mechanical engineering, manufacturing engineering, industrial engineering, material sciences) or an engineering technical field is required. 5+ years of experience in similar manufacturing / engineering position or equivalent. 3+ years' experience in CNC machining and/or other manufacturing processes. Demonstrated engineering experience in a high precision machine shop and/or assembly environment with moderate to high complexity products. Experience and demonstrated proficiency in the use of Mastercam, Solidworks, CREO/ProE or other CAD/CAM software.

Experience/Educational/Training Preferred:

Experience in medical devices manufacturing is highly preferred. Knowledge of 3D printing preferred

Knowledge, Skills, and Abilities:

Strong interpersonal skills: Ability to relate to and work with diverse groups of people. Coordinates project activities and resolves individual conflicts and issues. Handles sensitive and confidential situations and materials. Strong working knowledge of manufacturing methods, processes (i.e. machining methods, forging process, automation, heat treat methods, finishing, and polishing, material handling, basic machine design and metal fabrication. Strong understanding of medical devices, orthopedic focus preferred. Understanding of GD&T and fundamental engineering principles Good knowledge of lean manufacturing principles and ability to implement of Lean and Six Sigma techniques in business and manufacturing systems Ability to develop collaborative relationships with customers, vendors, and team members within the organization.

Teamwork:

Pursue trust for each team member. Seek and deliver honest feedback to all team members. Committed and accountable to achieving team goals. Demonstrated organizational skills with the ability to handle and prioritize multiple projects/tasks simultaneously in a timely manner in a fast-paced environment. Possess engineering, analytical and problem-solving skills Proficient in modern computer aided design (CAD) software, Solidworks or NX preferred Proficient in modern computer aided manufacturing (CAM) software such as MasterCam Knowledge of applicable regulatory requirements and concepts including

ISO 13485, ISO 14971, MDR

2017/745, CAPA, NCR, supplier control, manufacturing control, design control. Knowledge of Design of Experiments, Control Plans, PFMEA, DMAIC Model. Sound written and oral communication skills. Ability to provide written and/or oral communication to management and technical staff audiences. Excellence in Microsoft Word, Excel, and PowerPoint Ability to prioritize and work independently with a sense of urgency Other Requirements Work Environment The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Physical Requirements While performing the duties of this job, the employee could be required to stand. The employee could frequently be required to walk; use hand to finger, handle, or feel; reach with hands and arms and talk or hear. The employee could be required to sit; climb or balance and stoop, kneel, crouch, or crawl. The employee could occasionally lift and or move up to 50 pounds. Specific vision abilities required by the job could include close vision, distance vision, peripheral vision, and ability to adjust focus. Travel Requirements Up to 10% Americans with Disabilities Act (ADA): Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The statements herein are intended to describe the general nature and level of work being performed by employees and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of the Company. Pay Transparency In order to support the Fair Compensation Strategy by the US Govt., HR Dept., clients are required to adhere to "Pay Transparency Law"; in the impacted states; that have mandated the employers to list the salary ranges in Job advertisements or postings for job opportunities and Job promotions.