Senior Manufacturing Engineer (VN155NB) at 40HRS, Inc.

We are seeking a highly motivated Senior Manufacturing Engineer with expertise in biotechnology hardware to join our manufacturing team. The ideal candidate will play a key role in scaling and optimizing the production of our proteomics platform. The candidate will collaborate with R&D, supply chain and contract manufacturing to ensure the highest product quality and most efficient production. This role involves developing and refining manufacturing processes, troubleshooting hardware issues, and driving continuous improvements in production efficiency and reliability.

Responsibilities

• Create and maintain accurate documentation of work instructions, processes, and procedures.
• Assist in preparing reports on system performance and status.
• Experience with process validation and scaling up from pilot to production.
• Proficiency in design for manufacturability and reliability.
• Drive continuous improvement initiatives in product design and manufacturing processes to enhance product quality, reliability, and efficiency.
• Works with development engineering team to reduce product costs through DFM and use of more efficient manufacturing processes, material selection, and design optimizations, ensuring scalability and cost-effectiveness in production.
• Evaluates manufacturing processes by designing and conducting production failure modes and effect analysis
• Develops manufacturing processes by studying product requirements, researching testing methods, and conferring with equipment vendors.
• Improves manufacturing efficiency by analyzing and planning workflow, space requirements, and equipment layout.
• Manage relationships with contract manufacturers, overseeing the transfer of manufacturing processes and ensuring that their operations align with our quality standards and product specifications.
• Assures product and process quality by designing testing methods.
• Provides manufacturing decision-making information by calculating production, labor, and material costs.
• Prepares product and process reports by collecting, analyzing, and summarizing information and trends.
• Completes design and development projects by training and guiding technicians.

Requirements

• 6-8 years of experience in manufacturing engineering with a focus on hardware within the biotechnology, medical device, or related industries.
• Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, or a related field.
• Proven experience with hardware assembly processes, electromechanical systems, and instrumentation production.
• Strong understanding of manufacturing processes, including machining, electronics integration, and assembly.
• Familiarity with DFM/DFA principles and experience in working with R&D and product engineering teams.
• Experience with CAD or CAM software (e.g., SolidWorks, AutoCAD) for reviewing and updating designs.
• Working knowledge of PLM & QMS systems such as arena.
• Hands-on experience in troubleshooting and resolving technical issues in a production environment.
• Knowledge of ISO 13485, GMP, or similar manufacturing standards in the life sciences or medical device industry.
• Strong problem-solving skills and the ability to work in a fast-paced, cross-functional environment.
• Excellent communication and collaboration skills, with the ability to work effectively across teams and independently.

Preferred Qualifications

• Experience with automation and robotics in a manufacturing setting.
• Knowledge of statistical process control (SPC) and Lean Six Sigma methodologies.
• Familiarity with product lifecycle management (PLM) software.

Featured benefits

• Medical insurance
• Vision insurance
• Dental insurance
• 401(k)
• Commuter benefits
• Disability insurance
• Paid maternity leave
• Paid paternity leave