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Project Manufacturing Engineer – Plastics
Ref No.: 18-00447
Location: Raynham, Massachusetts
Position Type:Contract
Start Date / End Date: 07/16/2018 to 11/14/2021
Position: Project Manufacturing Engineer - Plastics

JOB DESCRIPTION
Provide both technical and project support within the GDC to include:
• Support the instrument product development process by providing technical guidance for new instruments
• Ensure that designs are optimized for molding, performance, and cost.
• Conduct analyses of all molding-related problems. Implement solutions and complete corrective actions as needed.
• Provide tactical leadership of specific instruments through development and supply ramp-up. Specific
responsibilities include:
o Lead on-going production calls with suppliers, design (R&D), QA, and purchasing. Capture discussions
and actions and communicate them to teams.
o Manage part-specific timelines inline with project milestones and communicate status to project team and
management.
o Identify and address technical- and business-oriented risks as they arise throughout these processes to
deliver accepted parts on schedule.
o Manage and track spending on development efforts and capital tooling for supported instruments.
• Provide verbal and written feedback to engineers and suppliers on specific concepts and designs in the form of
Design-for-manufacturing/molding (DFM), Design-for-Assembly (DFA), and Design-for-Inspection (DFI).
o Feedback to include cost, feasibility, inspection impacts with respect to manufacturing processes,
including injection/insert molding (process and tool design), metals machining, EDM, & assembly
operations.
• As part of DFM guidance, solicit or directly provide cost guidance for new concepts on a part- and feature-specific
basis. Manage cost data to provide historical and aggregate summaries through development process.
• Assist with technical inputs on identifying and qualification processes with external molding and polymer material
suppliers.
• Work closely with purchasing to develop strategic suppliers and making specific vendor selections for molded
instruments.
• Identify, manage and provide priorities and direction to molding vendors to satisfy manufacturing and development
requirements for part and tool manufacturing, material compounding, molding components and component
inspections.
• Perform technical reviews of tooling and fixture designs, including complex injection mold tools. Provide
constructive feedback and work with vendors to ensure tooling is appropriate to meet product specifications.
• Work with Quality Engineering in creation and execution of appropriate process validations and verifications for
new instruments.
• Select and validate new polymer materials for molding applications. Specify molding parameters required to utilize
medical-grade absorbable polymers.
• Establish policies and procedures to support defining all molding operations including the development process and
interaction with our Client's resources (leveraging best practices, processes, and vendors).
• Coordinate fabrication and delivery of prototypes and test pieces for new concepts using internal and external
supply points to support surgeon and team meetings.
• Attend project core team (PCT) and other on-going meetings (weekly teleconferences) to represent manufacturing
engineering and discuss topics of impact to the supply side of the development process.

JOB REQUIREMENTS
• Understanding of instrument manufacturing processes including injection molding, metal machining, and
assembly.
• Ability to read engineering drawings
• Excellent analytical and problem solving skills, with attention to detail.
• Ability to work on multiple projects simultaneously, including performing project management aspects.
• Proficient oral and written communication skills. Particular focus on:
o Presentation skills to communicate project information to internal and external parties.
o Telephone / computer communications as most interacting parties (suppliers, R&D,
purchasing, etc) are at remote locations. Participation in daily calls and teleconferences is
required.
• Self-motivated and able to advance own knowledge through training, independent investigation and
observation.

EDUCATION/SPECIAL TRAINING/EXPERIENCE:
• Bachelor of Science degree in Engineering (Plastics, Molding, Mechanical, or Chemical) is required.
• Bachelor of Science degree in Plastics / Molding Engineering, with emphasis on polymer materials and
molding applications is preferred.
• Masters degree in Plastics / Molding Engineering preferred
• 3 years minimum experience in molding and plastics engineering required
• Experience in writing and executing molding equipment validations and molding process validations is
required.
• Experience with part fabrication via machining operations (milling, turning, EDM, assembly) and sheet
forming is strongly preferred.
• Experience in medical device development and/or production is preferred, including knowledge of
ISO13485 is strongly preferred
• Knowledge of mold tool design and production and history of providing design for manufacturability
(DFM) feedback to R&D on new molded parts is preferred.
• Experience in working on new product development teams for new molded part, including molding
supplier selection, qualification and management is a must
• Knowledge of material characteristics and molding processes of medical-grade absorbable polymers
• Experience in compounding of polymers, with preferred experience in medical-grade engineering
polymers
• Statistical analysis knowledge required, including an understanding and ability to execute Design of
Experiments
• Knowledge of ANSI drafting standards and ISO geometric tolerance standards desired
• Financial analysis knowledge of mold costs, processing costs, and molded piece part component costs
desired

Candidate will be responsible for many aspects of instrument development and supply, with a focus on
instruments incorporating polymer materials. Responsibility includes Design-For-Manufacturability (DFM) and
prototyping support of R&D concept development as well as manufacturing engineering support of both
internal and externally1` sourced instruments. Analyze potential mfg process challenges relating to the design,
quality, and functionality of components both new and in production. Support of production instruments
molding is exclusively with external suppliers (not internal molding). Work on project core teams with R&D,
Purchasing, Quality Engineering, and outside vendors to assure timely development and validation of hybrid
(metal-plastic) designs, molds, polymer materials, and finished good instruments.
This position will provide both technical and project support within the GDC. Within the GDC, the candidate will
support the instrument product development process by providing technical guidance for new instruments, and manage
part-specific timelines inline with project milestones and communicate status to project team and management. Identify
and address technical- and business-oriented risks as they arise throughout these processes to deliver accepted parts on
schedule. Manage and track spending on development efforts and capital tooling for supported instruments.
This position will provide verbal and written feedback to engineers and suppliers on specific concepts and designs in the
form of Design-for-manufacturing/molding (DFM), Design-for-Assembly (DFA), and Design-for-Inspection (DFI). As
part of DFM guidance, solicit or directly provide cost guidance for new concepts on a part- and feature-specific basis.


Qualifications:
A minimum of a Bachelor of Science degree in Engineering is required, preferred concentration in Plastics,
Molding, Mechanical or Chemical. A minimum of 3 years experience in molding and plastics engineering is
required. An understanding of manufacturing processes including injection molding, metal machining, and
assembly is required. Ability to read engineering drawings is required. Experience in writing and executing
molding equipment validations and molding process validations is preferred. Experience with part fabrication
via machining operations (milling, turning, EDM, assembly) and sheet forming is strongly preferred.
Experience in medical device development and/or production is preferred, including knowledge of ISO13485 is
preferred. Knowledge of mold tool design and production and history of providing design for manufacturability
(DFM) feedback to R&D on new molded parts is preferred. Experience in working on new product
development teams for new molded part, including molding supplier selection, qualification and management is
preferred. Knowledge of material characteristics and molding processes of medical-grade absorbable polymers
is desired. Experience in compounding of polymers is preferred, with preferred experience in medical-grade
engineering polymers. Statistical analysis knowledge required, including an understanding and ability to
execute Design of Experiments. Knowledge of ANSI drafting standards and ISO geometric tolerance standards
is desired. Financial analysis knowledge of mold costs, processing costs, and molded piece part component
costs is desired. Excellent analytical and problem solving skills, with attention to detail are required. Ability to
work on multiple projects simultaneously, including performing project management aspects is required.
Proficient oral and written communication skills are required. This position is based in MA and may
require travel up to 10%.