Massachusetts: Manufacturing Engineer (231528)

Engineering Services
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Job Description:

Our client is seeking a Manufacturing Engineer for a 1 year contract. The candidate is expected to perform specific and general assignments / projects that provide innovative, functional, and cost-effective solutions to support product development and commercialization in a team-based environment. The Sr. ME is responsible for supporting external contract manufacturing line optimization activities and mitigating respective risks for a new product launch. The Sr. ME will ensure that robust processes are in place through adherence to established quality, design control processes and good engineering / manufacturing practices.

Responsibilities:

  • This role may require intermittent travel to and from the primary CMO based in New Hampshire.
  •  This is a hybrid role where the candidate may work from home a portion of the week as needed.
  • Must have a working knowledge of design control for medical devices and guidelines for drug development
  • Able to design and develop assembly and process related fixtures via CAD (Solidworks preferred) to improve throughput and reduce process risks
  • Able to collaborate with external suppliers and CMOs to define and document processes as well as their failure modes and related risks.
  • Experience with creating master process validation plans and qualification activities (i.e., IQ/OQ/PQ)/
  • Experience in executing validation and qualification activities including: creating protocols and methods, managing progress, interpreting data, and making informed recommendations.
  • Able to design and develop assembly and process related fixtures via CAD (Solidworks preferred).
  • Work with upstream R&D, Marketing, Quality and Manufacturing team members to identify manufacturing, material and/or product improvement opportunities and provide innovative product, system and component solutions.
  • Perform detailed design and process analysis and provide feedback or approval for detailed component and equipment specifications.
  • Ability to create/modify site procedures and train associates as required to commercialize manufacturing changes.
  • Solid working knowledge of SAP workflows (BOM, router creation, documents, inspection plans)
  • Change Management for product, labeling and packaging.
  • Apply knowledge of general engineering principles, materials, DFMEA, PFMEA and reliability to achieve product requirements.
  • Proficient in analytical problem-solving techniques.
  • Provide hands-on technical support for product development team with validation and implementation of engineering changes.
  • Actively participates in project / design reviews. Presents updates at project reviews.

 

Required Experience:

  • Education: BS or MS engineering degree (preferably Mechanical, Industrial, Chemical Engineering).
    3-4 years of product engineering and design transfer-related experience required in medical device or pharmaceutical industry working in a team-based environment
  • Proficient in Solidworks
  • Ability to communicate effectively through multiple modes in order to address project needs
  • Experience in implementing cost reduction initiatives
  • Excellent Technical writing skills and proficient use of statistical techniques (e.g. Minitab software)
  • Process Excellence training or certification (ex. Six Sigma, Lean Green or Black Belt) is a plus.
  • Knowledge and understanding of ISO and GMP.
  • Comfortable with ambiguity and able to make progress in the face of uncertainty. Able to discern the most important questions to be addressed and identify a path to answer them fully in a compliant manner
  • Solid verbal and written communication skills, strong decision making and problem-solving skills
  • Ability to apply production related statistics is desirable
  • Able to adapt to shifting priorities and work in a fast-paced environment.
  • Able to take initiative and be self-managed.
  • Practical, hands-on approach to problem solving. Able to take initiative and be self-managed
  • Demonstrate knowledge of product design and development
  • Product / Process Validation knowledge (FAT MVP, IQ, process development, OQ, & PQ)
  • Solidworks (CAD) skills

 

 

Massachusetts: Manufacturing Engineer (231528)

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About Black Diamond Networks
Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Start Date
ASAP
State
Massachusetts

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