Senior Engineer

JOB SUMMARY Mid-Level Mechanical Engineer to drive design, design verification, manufacturing scale-up, automation, continuous improvement, and sustaining engineering initiatives. Operating within an ISO 9001 quality management system for diagnostics and medical devices, this role bridges the gap between R&D and production. The Sr. Engineer will own design transfers, optimize manufacturing performance, solve complex technical problems independently, and contribute directly to new product development. Working in a fast-paced CDMO environment, they will collaborate cross-functionally to improve product quality, reduce costs, and support strategic client initiatives from concept to commercialization. ESSENTIAL DUTIES AND RESPONSIBILITIES Leads design and development of moderately to highly complex diagnostic sub-assemblies and modules (e.g., fluidic cartridges, optical interfaces, electromechanical systems), owning execution from concept through verification and design transfer with minimal supervision. Design diagnostic sub-assemblies and modules like fluidic cartridges, optical interfaces, and electromechanical systems from concept through design transfer using SolidWorks. Apply advanced GD&T and perform tolerance stack-up analyses to ensure high-yield manufacturing and proper component fit. Perform engineering analyses including structural, thermal, fluidic, and FEA, validating results through hands-on prototyping. Own technical decisions within assigned scopes, balancing trade-offs between performance, cost, manufacturability, and quality standards. Implement manufacturing automation and continuous improvement initiatives to increase throughput, optimize processes, and reduce production costs. Support production lines by troubleshooting daily technical issues to improve line efficiency and on-time delivery. Lead root cause analysis (RCA) for component or process failures and implement robust corrective/preventive actions. Manage engineering changes seamlessly from initial identification through final production release. Develop and execute verification and validation (V&V) plans, including hands-on testing of fluidic and electromechanical systems. Maintain documentation and Design History Files (DHF) in strict compliance with ISO 9001 and client quality standards. Interface with customers directly through regular technical meetings, milestones, and design reviews. Collaborate with suppliers to resolve technical fabrication issues, source components, and ensure part quality. Work as directed by manager. Health & Safety: Report and take required action regarding injuries, incidents, medical, and accidents required by policy. Make the health, safety, protection of rights, and the development of all employees your primary responsibilities. Effectively manage medical and first aid emergencies. Follow all agency safety/medical related policies and procedures. Follow fire evacuation and disaster procedures correctly and in a timely manner. Report unsafe situations immediately; ensuring safety is imperative. Ensure pertinent emergency telephone numbers are readily available. Report symptoms and signs of communicable diseases immediately. Consistently use universal precautions. Report any incident that could potentially result in negative reactions from the community, law enforcement officers, and other agencies to the supervisor immediately. EDUCATIONAL REQUIREMENTS, QUALIFICIATIONS, and TRAININGS Bachelor’s degree in mechanical engineering or a related technical discipline. Experience: 5–8 years of progressive engineering experience, ideally within a regulated product environment. CAD Expertise: Proficiency in SolidWorks for component and assembly design. GD&T & Tolerance Analysis: Strong expertise in geometric dimensioning and tolerancing, including complex tolerance stack-up analysis. Quality Systems: Solid understanding of ISO 9001 requirements, design controls, and maintaining Design History Files (DHF). Engineering Operations: Practical experience managing engineering changes via ECO/ECN workflows. Problem Solving: Demonstrated experience leading root cause analysis (RCA) and implementing corrective actions (CAPA). Testing & Validation: Hands-on experience developing and executing engineering verification and validation (V&V) plans. Process Optimization: Ability to independently develop, improve, and standardize engineering and manufacturing processes. Communication: Strong communication skills with a proven ability to present technical data clearly to managers and clients. Preferred Qualifications Advanced Degree: Master’s degree in mechanical engineering or a related technical discipline. Automation Elements: Hands-on experience working with stepper motors and PLC systems. Industry Experience: Prior experience in contract manufacturing (CDMO) or ISO 9001 medical/diagnostic device environment. Specialized Systems: Practical experience with fluidics, microfluidics, or precision piston pump technologies. Prototyping & Fabrication: Hands-on experience working in a machine shop environment. Testing & Tools: Experience in test method development and using Python coding for engineering data analysis. Professional Certifications: Lean Six Sigma Green Belt, PMP, or equivalent continuous improvement certifications. COMPUTER AND SOFTWARE REQUIREMENTS Microsoft: Office 365; SharePoint; Teams; Visio; and OneNote preferred. Epicor experience preferred. Ability to operate media equipment such as tablets, smartphones, and other electronic equipment. Ability to work with general office equipment. Ability to work with and understand databases a must and the ability to learn technical skills. PHYSICAL REQUIREMENTS & WORK ENVIRONMENT Shall have essential physical skills; be able to run, squat, stoop/bend, kneel, climb stairs, be able to lift at least 50 pounds (or ¼ own body weight). Shall have adequate vision, reading, writing, and documentation skills, and hearing to perform the essential functions of the job. Must have enough endurance to perform tasks over long periods of time. Will be engaged in speaking, sitting, walking, driving, listening, and in communicating both orally and in writing while performing his or her duties. Must be able to listen and respond to questions and instructions. The qualifications, physical demands, and work environment described herein are representative of those an employee will encounter and must meet to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities. This document does not create an employment contract, implied or otherwise, other than an "at will" relationship . Arcmed is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. The above noted job description is not intended to describe, in detail, the variety of tasks that may be assigned but rather to give the incumbent a general sense of the responsibilities and expectations of his/her position. As the nature of business demands change, so, too, may the essential functions of this position.