Mechanical Engineer

Job Title:

Mechanical Engineer

Job Description

This role focuses on driving cost reductions in complex automated vial-filling robotic systems while maintaining high standards of quality, reliability, and regulatory compliance. The Mechanical Engineer will analyze and optimize mechanical designs, Bills of Materials, and manufacturing approaches to reduce total product and production costs. The position works closely with cross-functional teams, including procurement, supply chain, R&D, Quality, Manufacturing, and Regulatory, to ensure cost-down initiatives are technically sound, manufacturable, and compliant with life sciences requirements.

Responsibilities

+ Perform detailed mechanical cost-down analyses on automated vial-filling robotic systems to reduce total product and manufacturing costs without compromising quality or compliance.

+ Analyze and optimize mechanical Bills of Materials (BOMs), identifying cost-saving opportunities through component consolidation, material substitutions, and design simplification.

+ Evaluate mechanical design inefficiencies such as over-tolerancing, over-engineering, and unnecessary complexity, and propose redesigns to improve cost, manufacturability, and reliability.

+ Conduct Design for Manufacturing (DFM) and Design for Assembly (DFA) reviews to reduce labor, assembly time, and production costs.

+ Collaborate with procurement and supply chain teams to identify and qualify alternate vendors and suppliers, and support vendor cost comparisons and negotiations.

+ Partner with cross-functional teams, including R&D, Quality, Manufacturing, and Regulatory, to ensure design changes meet applicable life sciences standards and regulatory expectations, including GMP and FDA-related requirements.

+ Validate cost-reduction initiatives through prototype builds, testing, and data analysis, ensuring changes achieve targeted cost and performance outcomes.

+ Maintain comprehensive documentation, including cost analyses, engineering change orders (ECOs), and validation reports, in accordance with internal processes and regulatory expectations.

+ Present findings, cost models, and recommendations to engineering leadership and key stakeholders in a clear and compelling manner.

+ Interpret and optimize complex assemblies and precision machinery, particularly robotic or automated equipment, to identify hidden cost drivers and improvement opportunities.

Essential Skills

+ Strong expertise in mechanical design principles, including materials selection and tolerancing for CNC machining and sheet metal components.

+ Expertise in robotics and automated equipment, especially in the context of complex mechanical systems.

+ Proven ability to perform cost analysis and cost modeling for mechanical systems and assemblies.

+ Experience applying DFM and DFA methodologies and lean engineering practices to reduce manufacturing and assembly costs.

+ Solid knowledge of supply chain dynamics and vendor sourcing strategies relevant to mechanical and electromechanical components.

+ Proficiency with CAD tools, with Solid Works preferred, for designing and analyzing mechanical components and assemblies.

+ Experience working with Product Lifecycle Management (PLM) systems to manage designs, changes, and documentation.

+ Ability to interpret, troubleshoot, and optimize complex assemblies and precision machinery, particularly robotic or automated systems.

+ Strong analytical mindset with the ability to identify hidden cost drivers across design, materials, and manufacturing workflows.

+ Understanding of life sciences regulatory requirements, including GMP and FDA-related expectations, and their implications on design changes.

+ Effective communication skills to influence and collaborate with cross-functional teams and stakeholders.

+ Bachelor's or Master's degree in Mechanical Engineering or a closely related field.

+ At least 5 years of experience in mechanical design, cost engineering, or product optimization, preferably in life sciences, medical devices, or pharmaceutical automation.

+ Demonstrated success in leading or contributing to cost-reduction initiatives for complex mechanical systems.

+

Experience with automated equipment, robotics, or precision machinery.

Additional

Skills & Qualifications

+ Experience in medical device, life sciences, or pharmaceutical automation environments.

+ Familiarity with supplier sourcing, vendor qualification, and working with global manufacturing environments.

+ Knowledge of quality systems and regulatory frameworks applicable to life sciences products.

+ Certification or formal training in Lean, Six Sigma, or Value Engineering.

+ Preferred experience with robotic equipment in a regulated or high-precision setting.

+ Experience in mechanical engineering design for cost, including cost engineering and value analysis.

+ Experience working with automated equipment and robotics in manufacturing or production environments.

Work Environment

The role centers on automated vial-filling robotic systems and other complex…