Manufacturing Engineer , Operations

General Summary

The mission of the Manufacturing Engineering group is to provide manufacturing technology and robust solutions that commercialize new products and that support continuous improvement in production. Project opportunities are designed to develop professional work knowledge and abilities and to support the efforts and projects that have global importance to the success of the business. Area of work involves manufacturing and business processes with interaction between production, cross-departmental engineering groups, and other cross-functional teams (such as Regulatory, Quality, R&D, Supply Chain, IT, etc.)

in executing and coordinating business operations systems projects and activities. Essential job functions include creating and executing an integrated cross-functional project plan.

• Solve problems and implement innovative solutions.
• Execute detailed root cause analysis and recommend vetted solutions.
• Effectively and succinctly communicate task or activity status, assumptions, risks, timeline, and escalations cross-functionally and interdepartmentally, as required.
• Assist with cross-functional coordination to implement changes and improvements to operational systems and processes, with knowledge and consideration towards requirements and inputs from cross-functional teams and key stakeholders. Assist with project risk management to successful completion of tasks and activities, appropriately escalating issues to management or leadership, as required.
• Approach problems from a detail-oriented perspective.
• Plan, schedule, conduct, and coordinate detailed phases of engineering work as part of a project or as a total project.
• Coordinate with the appropriate suppliers and other external resources needed in developing and implementing process improvement plans.
• Participate in project planning and scheduling.
• Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures.
• Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company.
• Ensure other members of the department follow the QMS, regulations, standards, and procedures.
• Perform other work-related duties as assigned.

* Indicates an essential function of the role

Minimum education and experience:

• Bachelor’s degree in Mechanical, Biomedical, Electrical, Chemical, Materials, or Industrial Engineering or related degree, or an equivalent combination of education and experience

Additional qualifications:

• 1+ year relevant engineering experience preferred
• Engineering experience in a manufacturing environment recommended, medical device industry preferred
• Excellent written, verbal and interpersonal communication skills required
• Knowledge of FDA regulations, Lean/Flow Manufacturing, and/or materials and manufacturing processes desired
• Proficiency in Word, Excel, PowerPoint, Access, and other computer applications required
• High degree of accuracy and attention to detail
• Excellent organizational skills with ability to prioritize assignments while handling various projects simultaneously

$80,000 to $105,000

• General office, laboratory, and cleanroom environments
• Potential exposure to blood‑borne pathogens
• Requires some lifting and moving of up to 25 pounds

The employee is frequently required to stand, walk, sit, and reach with hands and arms, and to use a computer, sitting for extended periods. Specific vision abilities required by this job include the ability to read, close vision, distance vision, color vision, peripheral vision, and depth perception.

• A collaborative teamwork environment where learning is constant, and performance is rewarded.
• The opportunity to be part of the team that is revolutionizing the treatment of some of the world’s most devastating diseases.
• A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long‑term disability insurance, 401(k) with employer match, an employee stock purchase plan, paid parental leave,…