About Us: Machine Solutions is the premier provider of advanced equipment and services for the medical device, biopharmaceutical, and blood- and plasma-collection industries. We support our customers' needs and growth by delivering quality and value through a wide breadth of products. Machine Solutions provides proprietary mechanical solutions to a variety of complex process, testing and device design challenges. Our equipment has become the industry standard for stent crimping, balloon catheter pleating and folding, catheter braiding and medical device manufacturing applications. As a pioneer in radio frequency technology, the company has continued to develop advancing technology for thermal forming, molding and welding plastic for medical manufacturing, biopharmaceutical, and blood- and plasma-processing applications. Our experienced team of engineers has been instrumental in automating manual processes that enable our customers to increase production volumes and profit margins, and we believe in providing a superior customer experience by designating resources to a dedicated aftermarket team that is always ready to provide technical service and process support. Machine Solutions is privately owned by BW Forsyth Partners, a Barry-Wehmiller company. BW Forsyth Partners is the investment arm of multibillion-dollar global manufacturing and engineering consulting firm Barry-Wehmiller. Established in 2009, BW Forsyth Partners blends Barry-Wehmiller's unparalleled legacy of value creation and people-centric culture development with keen investing experience to help companies realize their true potential. With a focus limited to areas known well, BW Forsyth Partners seeks to partner with leadership teams to acquire small- to middle-market companies in the capital and component equipment, and professional services sectors. In each of our operating companies, BW Forsyth Partners deploys operational improvements and strategy development without compromising the autonomy, strategic vision and entrepreneurial spirit of their leadership teams. Job Description: POSITION: Mechanical Engineer, NPD DEPARTMENT: Engineering REPORTS TO: Product Development Leader COMPANY SUMMARY: Machine Solutions, Inc. (MSI) is a pioneer and leading supplier of medical product process and testing equipment. Machine Solutions has been instrumental in automating or semi-automating manual processes within stent and catheter manufacturing organizations. We offer an excellent opportunity for highly motivated individuals in a fast-paced, biotech organization. GENERAL PURPOSE OF JOB: Research, design, develop, and test all aspects of mechanical components, equipment, and machinery for new product development. ESSENTIAL DUTIES AND RESPONSIBILITIES: Research design options and perform experiments to determine potential design feasibility or application. Construct prototypes; evaluate and document their performance; identify possible improvements Responsible for design/development activities which may include leading, participating in, coordinating or supporting: Concept, planning, design and execution stages Risk assessment Prototyping/testing Design reviews Verification & Validation Ability to handle multiple projects simultaneously Drive the verification and validation activities throughout the development lifecycle, including the creation of test plans, test protocols, and execution of tests to demonstrate system performance and compliance. Collaborate with cross-functional teams, including hardware engineers, software engineers, regulatory specialists, and quality assurance professionals, to define system requirements, specifications, and design parameters Conduct risk assessments and hazard analyses, identifying potential issues or design flaws, and proposing appropriate mitigation strategies to ensure patient safety. Designs, develops, and tests all aspects of mechanical components, equipment, and machinery. May integrate components to produce the final design; and evaluate the design's overall effectiveness, manufacturability, cost, reliability, and safety. Contribute to the creation and maintenance of engineering standards, processes, and best practices, fostering continuous improvement in system engineering methodologies. In addition to design and development, the position may require production supervision of parts and equipment, determine the causes of component failure, and test manufactured products to maintain quality. Position may be required to assist and communicate with customers the technical aspects of the product and assist in product planning, installation, and operation. Position is responsible for appropriately documenting design and processes related to the end product. Position will utilize Solidworks and Enterprise PDM to create and store CAD files electronically that can then be viewed, printed, or programmed directly into automated manufacturing systems. Position may require the use of Solidworks Simulation to evaluate components or assemblies against design requirements. Position will also prepare variations and changes to current design drawings Ad-hoc projects as needed Travel to other divisions and customer sites as needed, around 5%. QUALIFICATIONS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Education and Experience: Bachelor's degree (B. A.) in Mechanical Engineering or related field from a four-year college or university and 5+ years mechanical engineering experience; or 10 years related experience, training, and education in mechanical engineering. Experience in product development design and documentation from concept through launch Ability to combine sound engineering principles and techniques with innovative ideas to create new products. Experience designing sheet metal, machined components, and packaging electromechanical assemblies. Strong design for manufacturability a plus. Familiarity with medical device regulations and standards, such as FDA QSR, ISO 13485, and IEC 60601, ensuring compliance throughout the product development lifecycle. Detail-oriented mindset, with a commitment to quality and regulatory compliance. Strong organizational and time management skills, with the ability to manage multiple projects simultaneously and meet project timelines. Solid understanding of systems engineering principles, including requirements management, system architecture, and system integration. Language Skills: Ability to read, analyze, and interpret common scientific and technical journals, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies. Ability to effectively present information to your specific group and top management. Math Skills: Ability to apply advanced mathematical concepts related to Mechanical Engineering such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis. Reasoning Ability: Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, etc.,) in its most difficult phases. Ability to deal with a variety of abstract and concrete variables. PHYSICAL DEMANDS: Minimal time will be spent, standing, walking, stooping, kneeling and crouching. Some time will be spent reaching with hands and arms, lots of time will be spent sitting, using hands to handle or feel. Lots of time will be spent lifting up to 10 lbs, and minimal time will be spent lifting up to 50 lbs. The following vision requirements are needed: Ability to adjust focus (ability to adjust the eye to bring an object into sharp focus) Close vision (clear vision at 20 inches or less) View computers monitor for extended periods of time. Utilize fine motor skills for precision human interface device (HID) inputs. WORK ENVIRONMENT: Minimal time will be spent near fumes or airborne particles, near toxic or caustic chemicals, in outdoor weather conditions, with risk of electrical shock, and with explosives. And some time will be spent working near moving mechanical parts. Moderate noise can be expected. At Barry-Wehmiller we recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job. If your experience is close to what you see listed here, please still consider applying. We know that our differences often can bring about innovation, excellence and meaningful work-therefore, people from all backgrounds are encouraged to apply to our positions. Please let us know if you require reasonable accommodations during the interview process. Barry-Wehmiller is an equal opportunity employer. M/F/D/V This organization uses E-Verify. Applicants may be subject to pre-employment screening which may include drug screening, reference checks, employment verifications, background screening and/or skills assessments. Company: Machine Solutions, Inc.
