Design Engineer, Single Use Systems & Components
Overview
You own the design and validation of single use assemblies and components for biopharmaceutical manufacturing at NewAge Industries. You work with commercial teams and customers to translate needs into compliant, reliable solutions, all under QMS requirements. You will lead cross-functional efforts with Manufacturing Engineering, Quality, and Production, delivering products that meet ASME BPE, FDA, and ISO standards. This role puts you at the center of customer-driven contract manufacturing, with direct impact on product improvements and cost reduction.
What You'll Do9
- 1Develop detailed designs for single use systems and components using CAD tools like SolidWorks or AutoCAD, following industry standards and customer specs.
- 2Collaborate with Sales and Engineering to define customer requirements and technical solutions, evaluating needs for existing or new products.
- 3Troubleshoot product and system issues, delivering tailored resolutions to maintain project schedules and quality.
- 4Create assemblies, detailed drawings, specifications, bills of materials, and technical packets, plus assembly and work instructions for custom designs.
- 5Write, execute, and conclude engineering test protocols for functional and performance testing of single use systems, complying with GMP standards.
- 6Lead assembly of proofs of concept (POCs) and perform technical evaluations to validate designs.
- 7Prepare technical documentation including validation reports and risk assessments, ensuring designs meet ASME BPE, FDA, and ISO regulations.
- 8Drive design optimization and cost reduction by identifying improvement opportunities and collaborating with Manufacturing and Supply Chain.
- 9Participate in customer design reviews, providing technical guidance and integrating feedback into final designs.
Requirements6
- 15+ years in design engineering, preferably in Bio-Pharm or life sciences single use systems, with project leadership experience.
- 2Bachelor's degree (B.S.) or 5+ years of related experience.
- 3Hands-on experience with CAD software (SolidWorks, AutoCAD, or similar).
- 4Strong understanding of fluid systems, pressure vessels, and sanitary design principles.
- 5Knowledge of validation practices and regulatory compliance (GMP, ASME BPE).
- 6Excellent problem-solving and communication skills.
Salary Insight
Salary not disclosed in listing
Location
Required Skills
Similar open positions
Explore active roles that match your skills and interests.
Sterling Engineering Inc.
VerifiedSenior Systems Engineer – Pharmaceutical Automation
You will own complete technical integration of complex pharmaceutical manufacturing equipment, from installation through qualification. This role centers on system-level engineering for two aseptic filling systems at a major pharmaceutical customer. You will lead IQ/OQ qualification activities, coordinate mechanical, controls, automation, and validation teams, and translate regulatory requirements into system specs. With direct exposure to customers and engineering leadership, you will influence system architecture and technical strategy for GMP-regulated environments. This position offers a clear path to Principal Engineer or Technical Leadership roles, supporting life-saving products.
Medline Industries, LP
VerifiedSenior Sr Engineer Design at Medline Industries
Lead complex product design initiatives driving cross-functional development teams. Own technical direction and ensure regulatory compliance while mentoring engineers. Deliver innovative medical devices through rigorous design processes and continuous improvement. Differentiate by shaping product vision and strategic execution.
Kitagawa - NorthTech Inc
VerifiedMechanical Engineer, Workholding Systems Design
You will own the design and development of standard and custom workholding systems for a global leader in precision manufacturing. Using Siemens NX and Teamcenter, you will produce robust 3D models, 2D documentation, and validate designs through FEA (Ansys). You will collaborate with customers and cross-functional teams to deliver solutions that meet exacting specifications. This role offers the chance to drive continuous improvement in a stable, 50-year-old company.
Actalent
VerifiedProcess Engineer (Contract) Hudson WI
We seek an experienced Process Engineer to lead technical development and scaling of aseptic manufacturing processes for innovative pharmaceutical and combination-device products. This consulting engagement involves defining future-state aseptic operations by translating feasibility findings into robust process designs equipment requirements and contamination-control strategies. The role requires collaboration with technical stakeholders equipment vendors and project teams to ensure scalable compliant manufacturing aligned with industry best practices. Ideal for seasoned aseptic professionals who enjoy solving complex technical challenges and influencing critical design decisions.
PDDN INC.
VerifiedSenior Design Quality Engineer, Medical Devices
As a Senior Design Quality Engineer, you will own end-to-end design quality for Class II/III medical devices, including software-driven and active implantable products. You will lead design controls, risk management, and SDLC compliance from concept through post-market. You will embed with cross-functional teams in a hybrid role (3 days per week) in Andover, MA, supporting audits and regulatory submissions. This contract role offers immediate impact on high-stakes product quality.
Globus Medical
VerifiedSenior Mechanical Engineer, Medical Devices
Join the R&D team at Globus Medical to own mechanical design for intraoperative neuromonitoring systems used in complex spinal and cranial surgeries. You will lead both sustaining and next-generation NPI projects from concept through commercialization, collaborating with Regulatory, Quality, Supply Chain, and Manufacturing. Work directly with surgeons and OR staff to translate clinical needs into tangible solutions. This role offers the chance to shape products that improve patient outcomes and drive innovation in a fast-paced medical device environment.