Job Location: Manufacturing Site,Woburn, MA (ongoing); 5 days/week on-site

Job Summary:

The Manufacturing Assembly Associate will have responsibility for assembling finished medical devices and supporting all aspects of manufacturing including staging of material, kitting, and material control. The individual will work closely with the Lead Supply Chain & Manufacturing Engineer and Quality to meet production goals.

Primary Responsibilities:

• Assemble micro subassemblies and top assemblies using a microscope utilizing fine hand coordination working from written procedures and instructions.
• Assemble using a variety of tools and/or equipment according to specification/process.
• Adhere to GMPs including work instructions, quality procedures, and inspection procedures.
• Accurately and completely fill out Lot History Records (LHR) documentation according to Good Documentation Practices (GDP).
• Perform in-process and self-inspections as required.
• Perform product testing and final assembly packaging including but not limited to pouch sealing.
• Follow environmentally controlled room procedures including good hygiene and gowning.
• Use Loctite and or other adhesive as required by the assembly process.
• Meet or exceed weekly production goals.
• Collaborate with manager, supply chain and program management to prioritize and plan work activities and adapt for changing conditions.
• Ensure work areas are kept neat, clean and organized as per company guidelines.
• Demonstrate a keen awareness of safety regulations and practices.
• Develop and maintain strong internal working relationships across MMS.
• Willing to be cross trained and perform other related duties as assigned.
• Receive material in ERP and transfer to Receiving Inspection.
• Kit material to work orders.
• Palletize product for sterilization.
• Label, pack, and ship product for final distribution.

Qualifications / Competency:

• Preferred Education Requirements:
• High School Diploma or equivalent.
• Preferred Experience:
• 5 years of prior medical device cGMP manufacturing experience in cleanroom preferred.
• Basic understanding of quality management systems and regulatory requirements (e.g., FDA, ISO).
• Familiarity with manufacturing processes, including assembly, testing, and inspection techniques.
• Must be able to read and understand procedures and specifications written in English.
• Good hand-eye coordination.
• Ability to complete qualification training.
• Experience performing pouch sealing, testing, and visual inspection.
• Exposure to use of common mechanical measuring equipment
• Good computer skills are required to support retrieval of drawings and work instructions as well as other job-related activities.
• Excellent communication and teamwork skills.
• Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail.
• Ability to adapt to changing priorities and handle multiple tasks simultaneously.
• Commitment to upholding high standards of quality and safety in all aspects of work.
• Able to self-motivate and work both independently and as part of a team.

Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Ability to work up to 8 hours using a microscope.
• Good dexterity, eye/ hand coordination
• Specific vision abilities required by this job include close vision, and ability to adjust focus.
• Ability to sit and/or stand for extended periods.
• Must be able to lift up to 30 pounds at times.

An Equal Opportunity Employer

We do not discriminate based on race, color, religion, national origin, sex, age, disability, genetic information, or any other status protected by law or regulation. It is our intention that all qualified applicants are given equal opportunity and that selection decisions be based on job-related factors.