ASG specializes in the development, qualification, and commercialization of drug delivery systems for biomedical products. We deliver integrated business and science solutions to foster healthier, safer, and more prosperous communities. Guided by our core values—service, client success, curiosity, respect, integrity, and accountability—we value diversity and prioritize collaboration and growth within our inclusive, team-oriented culture. Check out our GOASG website.
As a Process Mechanical Engineer, your role involves a combination of developing, designing, implementing, and verifying solutions for the assembly and packaging of devices or other equipment for commercial devices. You will be responsible for completing your role with little or no supervision. Overall, your role as a Process Mechanical Engineer requires a clear understanding of process mechanical engineering principles and the ability to effectively communicate and collaborate with others to achieve team and project goals.
Experience in medical device verification and validation activities, including Design Verification, Design Validation support, test method development and validation, and technical documentation throughout the product development lifecycle in accordance with applicable regulatory and quality requirements is a distinct advantage.
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Stay updated on process mechanical engineering trends and emerging technologies.
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Provide technical expertise and collaboration with acquirers, suppliers, and solution delivery teams.
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Maintain current knowledge of medical device Design Controls, Verification and Validation methodologies, ISO 13485, ISO 14971, FDA Design Controls, and applicable international standards.
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Assist in tooling activities by providing technical expertise and collaboration in injection molding tooling.
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Stay updated on injection molding trends and emerging technologies, such as micromolding.
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Assist in project leadership by establishing project technical scope, priorities, and execution sequences; aligning technical scope with team member skill sets; and informing and consulting with project, supplier, and acquirer leadership on technical status, challenges, and options to ensure projects meet objectives for scope, time, and budget.
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Assist in design activities by analyzing stakeholder needs; identifying, negotiating, prioritizing, and quantifying solution architecture and functional elements.
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Conduct and document design reviews in collaboration with team members, suppliers, and acquirers.
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Assist in engineering activities by identifying, negotiating, prioritizing, and quantifying mechanical and electrical packages and components.
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Analyze and implement CAD-generated drawings and schematics.
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Assist in risk management activities by conducting, documenting, reviewing, and updating Failure Modes and Effects Analysis (FMEA), Fault Tree Analysis (FTA), and Control Plans.
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Lead the planning, development, and execution of Design Verification activities for medical devices and combination products.
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Design, engineer, and validate industry-compliant assembly and packaging solutions for production readiness, including documentation packages.
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Engage and monitor procurement, fabrication, assembly, and solution integration activities and processes.
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Provide oversight as appropriate to project agreements and collaborate on integrating solutions into a production environment.
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Participate in the execution and review of verification activities.
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Identify and document process verification items, cases, and scripts.
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Define, document, and conduct Design of Experiments (DOE).
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Ensure the highest level of compliance with industry standards, safety regulations, and quality control requirements.
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Engage suppliers as active stakeholders on the acquirer's behalf and inform acquirers of technical challenges and solution options.
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Advise and consult on product design impacts related to manufacturing, assembly, and packaging.
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Engage, inform, advise, and consult with acquirers, suppliers, and solution delivery teams.
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Bachelor's degree in Biomedical Engineering , Mechanical Engineering or a related field.
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2–5 years of experience in Mechanical Engineering or a related role.
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Proficient knowledge of process mechanical engineering principles and practices, including sequential and concurrent material flows, safety by design, quality by design, pneumatics, and intelligent actuators and sensors.
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Proficient knowledge of assembly, mechanical process sequential operations design, power (electrical and pneumatic) distribution, mechanical component fabrication, machining, and tolerance verification.
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Proficient skills in critical thinking and analytical reasoning, including applied mathematics corroborations, rationale, decision dependencies, technical critical path analysis, and strategic-tactical alignment.
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Proficient skills in systems thinking, conceptual awareness of interdependency, systems analysis, and systems engineering.
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Proficient communication skills, including practical and reflective listening, along with clear, concise, and objective oral and written communication.
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Proficient in project management.
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Proficient in performing effective time management and organizational and personal capabilities.
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Proficient in problem-solving, cause-and-effect identification, decomposition of primary and contributory causes, and collaborative engagement of trade space alternatives.
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Proficient in demonstrating collaboration, challenge resolution, communication effectiveness, urgency negotiation, organization priorities, accountability, and work product integrity.
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Proficient in overseeing small- and medium-scale projects.
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Ability to perform process engineering skills independently.
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Proficient ability to lead the development of new plastic injection tooling projects to meet a wide range of product performance and cosmetic requirements.
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Proficient ability to lead and refine the design for the manufacturing process by collaborating with supply management, product design, industrial design, and manufacturing engineering groups on material selection, design feasibility, and aesthetics of new plastic part and tooling designs.
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Proficient ability to research and identify new materials, manufacturing technologies, and finish options.
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Proficient ability to inform prototype and production manufacturing cost estimations, including tooling, secondary assembly, secondary finishing, and piece part costs.
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Accountability: Owning the consequences of your decisions and actions.
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Integrity: Complete harmony in what you think, say, and do concerning the ASG Way and our Code of Conduct.
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Respect: Treating people how you want to be treated, whether or not you agree with them.
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Curiosity: An enduring desire to learn and grow.
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Client Service: Results that address client needs based on client decisions.
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Service: Giving priority to enriching the lives of others.
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