Overview

The manufacturing engineer will report directly to the engineering manager for Systems and Hardware. This engineer will have responsibility for creation of new documentation and the maintenance of that documentation in an ISO regulated plant.  This position will actively support the manufacturing of Marlborough based product lines. The successful candidate will actively work with all levels of manufacturing and service personnel, product management, Quality, and planning.  You will be responsible for the training of manufacturing personnel.

Responsibilities

·        Work with Service, Manufacturing, Product Management, R&D, and Planning as a technical engineering lead.

·        Manage the implementation of new processes along with updating older processes.

·        Work will include managing drawing and model updates in SolidWorks along with releasing them according to appropriate Quality processes.

·        Creation of SOP’s, testing procedures and batch records, as well as bills of materials. 

·        Identification of test equipment and work cell build-out.

·        Work within Salesforce to respond to customer complaints as they relate to a need for a service repair or replacement part.

·        Become the expert on current and new processes for introduction of 908 devices to Marlborough.

·        Work closely with Quality Engineers & Product Support Engineers focused on alignment of newly created documentation and product introductions.

·        Identify and resolve process and quality related problems for assigned processes.

·        Provide accurate and timely project reporting to internal and external stakeholders.

·        Communicate effectively with engineering staff and cross functional departments.

·        Align with the Repligen’s EHS (Environmental Health & Safety) culture to foster a safe work environment and strive for continuous improvement.

·        Encourage support and participation in EHS activities and programs.

·        Proactively identify and report EHS issues (hazard IDs) or events (near misses, incidents). Participate in progressing process improvements and corrective actions.

Qualifications

·        BS Mechanical Engineering degree

·        2-5 years of engineering experience in a fast-paced manufacturing or product development environment. 

·        Demonstrated track record of successful project leadership and execution

·        Excellent presentation, verbal and written communication skills

·        Ability to lead in a cross functional team environment

·        SolidWorks experience in both components and assembly drawings (required)

·        Experience with any/all of the following processes a plus: hardware and systems design/assembly, fluidic testing, fabrication of sheet metal, and machined metal and plastic parts

·        Able to work with outside vendors and manage their assigned work

·        Self-starter with plenty of drive.

·        Ability to demonstrate Repligen R-Values and coach others on such principles.

·        Experience of leading by example and adhering to safety protocols, safe work practices, and PPE (Personal Protective Equipment) requirements.

What Repligen Offers

Repligen offers you a competitive remuneration package, including a yearly bonus, non-contributory pension, generous PTO, partial compensation on your personal health insurance and flexible working hours. But most importantly Repligen offers you a stimulating, collaborative environment with steep learning curves and the opportunity to contribute to the healthcare of patients worldwide. All of this with an international team in Waltham, MA.