MillenniumSoft Inc · 5 months ago
Product Development Engineer 1
MillenniumSoft Inc is a company that specializes in medical devices, and they are seeking a Product Development Engineer 1. This entry-level role involves supporting technical projects for the design and development of new and existing products, applying engineering fundamentals, and ensuring compliance with quality and safety regulations.
Staffing & Recruiting
Responsibilities
Support technical and/or cross-functional project work to further design and development activities for new and existing products
Apply engineering fundamentals, concepts and practices to advance new product development efforts
Demonstrate basic understanding of design control process
Develop raw material and in-process inspection test methods as well as test method validation (i.e., MSA, Gage R&R)
Support installation and qualification of R&D equipment
Perform data analysis and write technical reports based on product design activities
Demonstrated ability to utilize statistical tools and computer analysis
Support purchasing process of materials, equipment and testing consumables
Ensure compliance with client quality policies, procedures and practices as well as with all local, state, federal and client safety regulations, policies and procedures
Personal leadership, team player, innovation/risk taker, results oriented, integrity, interpersonal skills, technical skills
Able to adapt to shifting priorities and work in a fast-paced environment
Comfortable with ambiguity and able to make progress in the face of uncertainty
Qualification
Required
Support technical and/or cross-functional project work to further design and development activities for new and existing products
Apply engineering fundamentals, concepts and practices to advance new product development efforts
Demonstrate basic understanding of design control process
Develop raw material and in-process inspection test methods as well as test method validation (i.e., MSA, Gage R&R)
Support installation and qualification of R&D equipment
Perform data analysis and write technical reports based on product design activities
Demonstrated ability to utilize statistical tools and computer analysis
Support purchasing process of materials, equipment and testing consumables
Ensure compliance with client quality policies, procedures and practices as well as with all local, state, federal and client safety regulations, policies and procedures
Personal leadership, team player, innovation/risk taker, results oriented, integrity, interpersonal skills, technical skills
Able to adapt to shifting priorities and work in a fast-paced environment
Comfortable with ambiguity and able to make progress in the face of uncertainty
BS degree in engineering is required
1-2 years of engineering experience is required, preferably in FDA regulated environment
1-2 years of acquaintance with cGMP's (21CFR211), 21CFR820 and ISO13485
Preferred
Mechanical or Biomedical Engineering preferred