Onsite: Beverly, MA
Compensation: up 145k + bonus
Job Overview

This role is responsible for the planning and coordination of project activities to meet higher-level schedules, contributing to long-term planning under supervision. The position involves independently addressing complex issues, collaborating with cross-functional teams, and overseeing supplier relationships. Key responsibilities include the creation, documentation, development, and implementation of processes related to assembly, testing, and manufacturing. The position also involves optimizing manufacturing processes, working closely with design engineers to ensure efficient, cost-effective, and high-quality product production.

Key Responsibilities:

• Conduct and report on evaluation testing, validation, and verification in alignment with regulatory standards (ISO, FDA) and company policies.
• Provide estimates for production timelines, staffing needs, and costs to inform management decisions.
• Collaborate with management and staff to address manufacturing capabilities, production schedules, and other related matters to streamline production.
• Utilize statistical analysis to troubleshoot production issues and perform root cause analysis.
• Propose improvements to current operations by implementing new methods, processes, and training initiatives.
• Manage equipment procurement and installation; perform IQ/OQ and PQ processes.
• Systematically address operational challenges impacting production.
• Prepare necessary documentation for manufacturing processes.
• Oversee project coordination and lead cost-reduction initiatives.
• Collaborate with R&D and other departments to create cost estimates for new product designs.
• Ensure compliance with safety, environmental, and design standards in coordination with regulatory agencies.
• Contribute to 'design for manufacturability' efforts as part of the team.
• Support the transition of new products from R&D to production.
• Create and update assembly instructions and manufacturing documents.
• Manage engineering change orders (ECOs).
• Control manufacturing costs through innovative approaches and fixture design.
• Monitor and assess product cost and provide support to the production floor.

Additional Responsibilities:

• Perform other duties as assigned by management or as necessary to support business needs.

Qualifications:

• Bachelor's degree in Mechanical or Manufacturing Engineering.
• Solid experience in interpreting engineering drawings/specifications and evaluating manufacturing processes.
• Familiarity with machine shop practices such as milling, turning, and grinding is beneficial.
• Experience with Six Sigma methodologies is preferred.
• Previous experience with automation is a plus.
• Proficiency in mechanical design, particularly using SolidWorks.
• At least 7 years of relevant experience, ideally within the medical device industry.
• Strong written and verbal communication skills, with experience in technical writing and procedure documentation.
• Ability to work collaboratively as part of a team.
• Excellent problem-solving and analytical abilities.
• Self-motivated with the ability to manage multiple tasks effectively.