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Manufacturing Engineer

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.

Average salary estimate

$80000 / YEARLY (est.)
min
max
$70000K
$90000K

If an employer mentions a salary or salary range on their job, we display it as an "Employer Estimate". If a job has no salary data, Rise displays an estimate if available.

What You Should Know About Manufacturing Engineer, Repligen

At Repligen, we’re looking for a Manufacturing Engineer to join our dynamic team in Marlborough. As a Manufacturing Engineer, you’ll work directly with the engineering manager for Systems and Hardware, playing a crucial role in creating and maintaining documentation in our ISO-regulated plant. You’ll support the manufacturing of our innovative product lines and be the go-to technical lead, collaborating with service, manufacturing, and product management, as well as Quality and Planning teams. In this position, you’ll manage process implementation and updates, dive deep into drawing and model revisions using SolidWorks, and create essential SOPs, testing procedures, and bills of materials. You’ll also identify test equipment and assist in work cell build-out, ensuring everything runs smoothly. Your role will include responding to customer complaints through Salesforce and becoming the expert on introducing new products to Marlborough. Regularly, you’ll work closely with Quality Engineers to ensure documentation aligns perfectly with product introductions. Your ability to identify and resolve process and quality problems will be vital. As part of our EHS culture, you’ll encourage safety improvements and partake in EHS-related activities. If you have a BS in Mechanical Engineering and 2-5 years of relevant engineering experience, this could be your next great adventure with us. Join Repligen, where you’ll enjoy a competitive remuneration package, a collaborative environment, and the chance to impact global healthcare positively.

Frequently Asked Questions (FAQs) for Manufacturing Engineer Role at Repligen
What are the main responsibilities of a Manufacturing Engineer at Repligen?

As a Manufacturing Engineer at Repligen, you will be responsible for creating and maintaining documentation in an ISO-regulated environment, supporting the manufacturing process, and working closely with various teams including Service, R&D, and Planning. Your responsibilities also include managing drawing updates in SolidWorks, creating SOPs and testing procedures, and resolving quality issues.

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What qualifications do I need to apply for the Manufacturing Engineer position at Repligen?

To be considered for the Manufacturing Engineer role at Repligen, you should have a BS in Mechanical Engineering along with 2-5 years of engineering experience in a fast-paced manufacturing or product development environment. SolidWorks experience is essential, as is a demonstrated ability in project leadership and cross-functional teamwork.

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How does Repligen support career growth for Manufacturing Engineers?

Repligen is committed to fostering a stimulating and collaborative environment, providing opportunities for steep learning curves and professional development. As a Manufacturing Engineer, you will have access to mentorship programs and resources to enhance your skills and advance your career while contributing to innovative healthcare solutions.

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What software skills are important for a Manufacturing Engineer at Repligen?

A Manufacturing Engineer at Repligen should be proficient in SolidWorks for managing components and assembly drawings. Experience with Salesforce for handling customer responses is also valuable, along with familiarity with processes involving hardware and systems design, fabrication, and testing.

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What is the company culture like for Manufacturing Engineers at Repligen?

Repligen promotes a collaborative and safety-focused culture where Manufacturing Engineers are encouraged to lead by example and adhere to best practices. You’ll be part of an international team dedicated to continuous improvement and innovative healthcare solutions, making your work environment stimulating and rewarding.

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Common Interview Questions for Manufacturing Engineer
Can you describe your experience with SolidWorks as it relates to the Manufacturing Engineer role?

In your response, emphasize projects where you've utilized SolidWorks to create or revise engineering drawings and assemblies. Highlight your familiarity with both components and assembly drawings, and explain how you ensure accuracy and adherence to quality processes.

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How do you handle process improvements in a manufacturing environment?

Discuss a specific example where you identified a process issue and implemented a successful improvement. Outline the steps you took, the collaboration with other departments, and the impact these changes had on efficiency or quality in your project.

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What strategies do you use to ensure compliance with ISO regulations?

Explain your understanding of ISO standards relevant to manufacturing. Share your experiences in documenting processes and procedures to comply with these regulations, and any specific audits or training you've conducted to uphold these standards.

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How do you manage cross-functional team dynamics as a Manufacturing Engineer?

Focus on your experience leading or collaborating with multidisciplinary teams. Discuss any tools or methods you've used to facilitate communication and cooperation among different functions, stress the importance of teamwork in achieving project goals.

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What have you done to maintain a safe work environment?

Speak about your commitment to safety protocols, share experiences of initiating safety programs or addressing potential hazards, and mention how you've encouraged participation from team members in safety activities to cultivate a proactive safety culture.

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How do you prioritize tasks when managing multiple projects simultaneously?

Describe your approach to prioritizing tasks based on urgency, importance, and project deadlines. Include examples of how effective time management and clear communication helped you stay on track while handling multiple responsibilities.

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Describe a challenging engineering problem you've faced and how you solved it.

Provide a scenario involving a significant engineering challenge, the steps you took to analyze the issue, the solution you implemented, and the results. This showcases your problem-solving skills and ability to tackle complex situations.

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How do you ensure quality control in manufacturing processes?

Discuss the techniques you use to monitor and maintain quality throughout manufacturing. Mention specific tools or methodologies you've applied, like Six Sigma or other quality frameworks, and how you collaborate with Quality Engineers.

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In what ways have you contributed to a team’s success in a manufacturing setting?

Reflect on your role in fostering collaboration, supporting colleagues in their tasks, or leading initiatives. Provide metrics or successes that resulted from your contributions to underline your impact on the team.

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Why do you want to work as a Manufacturing Engineer at Repligen?

Convey your enthusiasm for the role by discussing your alignment with Repligen’s mission in healthcare, what you find appealing about the company culture, and how your skill set would contribute positively to the team.

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HQ LOCATION
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EMPLOYMENT TYPE
Full-time, on-site
DATE POSTED
April 2, 2025

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