Senior R&D Engineer - Packaging (Mansfield, MA)

Smith+Nephew•Mansfield, MA

3d•$110,000 - $164,725•Onsite

About The Position

Life Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living. Join a thriving Product Development Team developing life-changing medical device technologies in the exciting field of sports medicine. As part of the Smith+Nephew Packaging Engineering team, you will significantly contribute to the success of new product launches through the development of innovative packaging systems in a collaborative, team-centric environment. What will you be doing? New Product Development: Designs and develops sterile and non-sterile packaging systems for new product development and existing product lines under limited supervision. Coordinates and monitors packaging projects and programs from inception through implementation. Establishes appropriate project schedules and prepares project reports periodically to outline progress. Defines packaging-related design inputs and requirements through voice of customers such as consultations with surgeons, nurses, or other operating room/hospital personnel. Provides technical packaging support and leadership to multi-functional teams, and lower level packaging engineers. Communicates effectively with multi-functional teams, such as R&D, Marketing, Clinical, Regulatory Affairs, Quality Assurance, Purchasing, and Operations. Develops protocols and reports for packaging feasibility studies and design verification for new products with little mentorship. Works effectively and builds relationships with Smith+Nephew packaging suppliers. Prepares reports/documentation using good documentation practices and effectively communicates results multi-functionally and vertically within the organization. Creates packaging cost estimates for COGS budget in each applicable business phase. Packaging Sustaining Engineering: Creates, reviews, and approves Engineering Change Requests for packaging for design changes as necessary. Effectively works with manufacturing process teams to implement new design changes. Assists in the development of standardized test procedures, polices, and standards. Leads and assists with Corrective and Preventative Actions (CAPA) projects as necessary. Leads or assists with business initiative packaging projects as the need arises. Prepares capital expenditure requests and written justification for assigned projects. Initiates purchase requisitions for prototypes, tooling, and other project related expenses. What will you need to be successful?

Requirements

Minimum 5 years of experience with a bachelor’s degree in Packaging Engineering related to the design and development of medical device or health care product packaging required.
2 years of experience with a master’s degree in Packaging Engineering related to the design and development of medical device or health care product packaging required.
Understanding of FDA, GMP, and ISO Guidelines
Solid understanding of ISO and ASTM and ISTA Standards
Proficient using CAD software to design packaging components including thermoformed and die cut parts, packaging assemblies, or similar component types.
Approximately 10%, including international travel

Nice To Haves

Certified Packaging Professional preferred
Medical Device Experience Preferred
SolidWorks proficiency is highly preferred.

Responsibilities

Designs and develops sterile and non-sterile packaging systems for new product development and existing product lines under limited supervision.
Coordinates and monitors packaging projects and programs from inception through implementation.
Establishes appropriate project schedules and prepares project reports periodically to outline progress.
Defines packaging-related design inputs and requirements through voice of customers such as consultations with surgeons, nurses, or other operating room/hospital personnel.
Provides technical packaging support and leadership to multi-functional teams, and lower level packaging engineers.
Communicates effectively with multi-functional teams, such as R&D, Marketing, Clinical, Regulatory Affairs, Quality Assurance, Purchasing, and Operations.
Develops protocols and reports for packaging feasibility studies and design verification for new products with little mentorship.
Works effectively and builds relationships with Smith+Nephew packaging suppliers.
Prepares reports/documentation using good documentation practices and effectively communicates results multi-functionally and vertically within the organization.
Creates packaging cost estimates for COGS budget in each applicable business phase.
Creates, reviews, and approves Engineering Change Requests for packaging for design changes as necessary.
Effectively works with manufacturing process teams to implement new design changes.
Assists in the development of standardized test procedures, polices, and standards.
Leads and assists with Corrective and Preventative Actions (CAPA) projects as necessary.
Leads or assists with business initiative packaging projects as the need arises.
Prepares capital expenditure requests and written justification for assigned projects.
Initiates purchase requisitions for prototypes, tooling, and other project related expenses.