Lead Mechanical Engineer

4 weeks ago

Cincinnati, United States Aprecia Pharmaceuticals Full time

General Purpose of Position : Provide mechanical engineering design expertise in the design and development of Aprecia's next generation additive manufacturing technology. The ideal candidate will have expertise in machine design, CAD/CAM, fabrication and manufacturing processes, with a focus on advanced additive technologies. Depending on project scope, will be a team member or may take project ownership with specifications definition, vendor management, and/or internal design/build/test responsibility. Familiarity with cGMP (current Good Manufacturing Practices) requirements is desired. Primary Duties and Responsibilities (Essential Functions) : Duties/Responsibilities 1 Collaborate with cross-functional teams to design and develop next-generation additive manufacturing machines, ensuring optimal performance, efficiency, and compliance with relevant industry standards. 2 Perform mechanical design and prototyping of design concepts and modifications to support 3DP process equipment and packaging equipment. 3 Conduct thorough design reviews, FMEAs, safety risk assessments, testing, and validation of new systems and components to ensure performance meets or exceeds specifications. 4 Manage relationships with external vendors, including the selection, coordination, and oversight of contracts and services. 5 Identify opportunities for continuous improvement in existing additive manufacturing machines and processes, applying innovative solutions to drive increased capability, efficiency, and cost savings. 6 Apply knowledge of cGMP standards to ensure the design and development process adheres to best practices in quality, safety, and reliability. 7 Maintain current knowledge of industry trends, advancements, and best practices in additive manufacturing, integrating this knowledge into the design and development process. 8 Ensure all documentation, including designs, specifications, and reports, are accurate, thorough, and compliant with relevant regulations and company policies. Reporting to this Position : No direct reports Travel : Position may require periodic travel (0-10%) Work Shift : This position typically works days but occasional support may be needed at other times Knowledge, Skills and Abilities : Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams. Strong problem-solving and critical thinking skills, with the ability to identify and implement innovative solutions. Proven experience managing external vendors and overseeing complex projects. Working knowledge of pharmaceutical industry and cGMPs Ability to learn and adapt to demands in a fast-paced work environment. Strong background in CAD/CAM software, finite element analysis, discrete element modeling, and other relevant engineering design tools Excellent working knowledge of GD&T and experience evaluating and managing tolerance stack-ups Ability to work in a hands-on collaborative fashion with many different disciplines both inside and outside of the company. Education and Experience : B.S. degree (or higher) in Mechanical Engineering, Mechatronic Engineering, or equivalent required 5-10 years' experience in machine design and development, with a focus on additive manufacturing or other advanced manufacturing technologies 5+ years' Solidworks and Solidworks PDM experience preferred. 1-2 years of engineering experience, preferably in a cGMP manufacturing environment such as pharmaceutical, nutraceutical, or equivalent process-related industry preferred. Experience in technology development and maturation from early proof-of-concept to production scale implementation, including but not limited to, concept development, detailed design, detailed drawing generation per ASME Y14.5, BOM management, fabrication oversight, assembly, testing, and troubleshooting Experience with designing automated manufacturing equipment for use by external customers preferred. Hands-on experience with 3D printing technologies preferred. Working knowledge of machine shop equipment operation, fabrication, and rapid prototyping highly desired Electrical and Controls engineering experience or other machine design/development relevant cross disciplinary skillset highly desirable Physical Demands and Work Environment : Ability to stand for extended periods of time within the operations areas wearing required PPE (personal protection equipment) Ability to sit for extended periods of time to document and analyze testing results Good manual dexterity to operate computer, general office, and engineering equipment Able to clearly document specifications and other engineering needs/results Fine motor skills to manage more delicate engineering movements Good eyesight to read technical/instructional materials and drawings Occasional odd body positions (kneeling, bending, reaching) may be required while working with engineering equipment Ability to wear appropriate PPE as required for exposure to pharmaceutical operations (e.g. respirators, over-gowning, gloves, etc.) GENERAL INFORMATION : The expectation for all employees is to support the company's mission, vision, culture and core values while adhering to all company policies. The above information is intended to describe the general nature and level of work being performed by individuals assigned to this position. It is not intended to be an exhaustive list of all duties, responsibilities, and skills required. The position may require other duties as assigned and can be changed at any time by the company. We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, genetic information, sexual orientation, gender identity, national origin, disability or veteran status.

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