The product Development Engineer will be responsible for developing, designing, documenting, and approving single-use systems for the biopharmaceutical industry, providing assistance and technical support to end-users necessary to ensure the successful implementation thereof.
DUTIES AND RESPONSIBILITIES
Ensures processes and products are compliant with GMP and compatible with the regulatory environment required by our pharmaceutical customer base.
Collaborates with other departments to ensure best practices are communicated throughout the organization.
Supports the Quality department via creation of SOPs, assisting with deviation or excursion responses, testing and analysis, etc.
Supports continuous quality improvement initiatives throughout organization.
Supports efficiency and lean manufacturing initiatives.
SINGLE-USE SYSTEM SPECIFIC:
Develops single-use systems designs based on user and process requirements:
o Creates product specifications which meet customer design requirements while allowing for lean production and cost-effective solutions.
o Analyses product specifications and performance requirements to determine designs which can be produced via existing component portfolio
o Prepares design layouts, assembly drawings, work orders, BOM's and other documents necessary for completion of projects.
o Generates pricing utilizing sophisticated models in concert with Global Finance and Accounting.
Manages library of single-use componentry for use in single-use assemblies:
o Evaluates single-use components to ensure fitness for purpose,
o Qualifies new components for use in production
o Works with Quality, planning, and procurement to ensure consistent supply
Supports single-use systems production:
o Ensures designs are manufactured accurate to developed specifications.
o Facilitates new design implementation.
o Promotes efficient and ergonomic manufacturing techniques.
o Interfaces with and offers continuous improvement support for the MES/ERP systems.
o Creates support documentation including process flow and recommended usage diagrams.
EDUCATION AND EXPERIENCE
Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, Manufacturing Engineering, Industrial Engineering, Industrial Technology or equivalent technical discipline
Industry experience is essential.
Advanced computer skills is essential including familiarity with CAD and proficiency in wordprocessing, spreadsheets, and databases.
Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.
Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
Ability to define problems, collect data, establish facts, and draw valid conclusions.
Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
Full eligibility to work in Ireland is required for this role - European Passport/Stamp 4 Visa
Contact brenda on 0858723761, firstname.lastname@example.org