MANUFACTURING ENGINEER II (2nd Shift)We Deserve the Best - And So Do You!High Growth CompanyOpportunity to Learn and GrowShape your CareerSee the Importance of Your WorkMillstone is a fast growing, fast paced medical service provider for the top Orthopedic companies in the industry. Millstone's business focus is sterile and non-sterile packaging of medical devices. Millstone also engages in other activities, such as mechanical inspection and assembly, which are designed to meet the outsourcing requirements of medical device manufacturers seeking to reduce costs while maintaining high levels of quality, accuracy, and timeliness. We are FDA and ISO registered and employ a detailed internal quality system to ensure ISO compliance.JOB SUMMARY:Millstone is seeking an energetic and engaged Sr. Manufacturing Engineer to identify and drive continuous improvement. As our Manufacturing Engineer , you will be responsible for developing and implementing mistake-proof processes, equipment, and tooling used to execute on critical cleaning and sterile packaging of orthopedic medical devices.Manufacturing Engineering (ME) is responsible for equipment selection, installation, validation, maintenance and calibration, improvements, documentation, spare parts, and of course Product Quality. As a Sr. Manufacturing Engineer, you will be in a position to ensure our legacy product lines are continuously improved and new product lines transition smoothly into full production, all while adhering to financial and scheduled commitments.RESPONSIBILITIES:- Developing, evaluating, improving and documenting manufacturing processes.-Develop, Document, and execute process validations on various types of manufacturing equipment.-Estimating staffing requirements, production times, and relative costs to provide data for operational decisions.-Working closely with manufacturing department to develop, coordinate, and implement technical training for employees.-Designing and developing manufacturing processes for enhancements, product changes, and new products, and related fixtures and tooling that are consistent with zero defect level and low product cost.-Maximizes efficiency by analyzing layout of equipment, workflow, assembly methods, and work force utilization.-Determines the parts, equipment and tools needed in order to achieve manufacturing goals according to product specifications.-Maximize the performance (quality, output volume, and cost of manufacturing processes by providing high impact technical/operational support, and by developing processes to the highest possible standards.-Apply a scientific approach to problem solving, combining analytical and experimental skills to maximize overall equipment effectiveness and efficiency.-Creating and maintaining accurate documentation of tool drawings, design concepts, shop orders, and concepts in accordance with the R&D, GMP and quality assurance functions.-Ensures that non-conforming products and processes are evaluated and corrected on assigned projects in accordance with process controls and procedures.-Providing engineering support in production department to trouble shoot and resolve technical problems.-Coordinating work with machine shops, assigned technicians, and outside vendors.-Facility Maintenance support as needed-Perform Calibration and Preventive Maintenance-Performs other duties as requested or required across all areas of the Company.KNOWLEDGE & SKILLS:
- B.S. Degree in Engineering with a minimum of 5 years of experience in medical device processing/manufacturing engineering/product development.
- Ability to work in a fast-paced environment with multiple priorities
- Exemplary verbal and written communication and organizational skills
- Ability to work with a team or independently with minimum supervision
- OEE, GMP Practices, lean certified, black belt in six sigma and Minitab proficiency is highly preferred
- Knowledge of, or experience with, automated systems or UV glue system is a plus
***THIS POSITION IS NOT ELIGIBLE FOR RELOCATION ASSISTANCE &/OR VISA SPONSORSHIP. ***ADDITIONAL INFORMATION:Millstone Medical Outsourcing offers a competitive salary, health, dental and vision benefits beginning on the first day of employment and 401K with company match. Other benefits include paid vacation, paid sick time, holiday pay and voluntary benefits in addition to an employee-centric work environment. To learn more about Millstone Medical Outsourcing, please visit us online at www.millstonemedical.com.Millstone Medical Outsourcing provides equal employment opportunity to all applicants and employees. No person is to be discriminated against in any aspect of the employment relationship due to race, religion, color, sex, age, national origin, ancestry, disability, sexual orientation, gender identity, genetic information, citizenship status, marital status, pregnancy, veteran status, or any other status protected by applicable federal, state, or local law. All employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check, consistent with applicable laws.