Engr 2, Product Development

We are reducing the level of experience to 1-5 years MUST haves Med device, Able to write test protocals, Valdiation, DOE, ISO 607, Change control, Technical writting . Will be designing and validating class 1.2, 3, Products TITLE Engr 2 Packaging Functions and Responsibilities Support the design, development, and qualification of packaging systems for sterile and non sterile medical devices under the guidance of senior engineers, ensuring compliance with applicable domestic and international standards

• Assist with the execution of design control activities for low to moderate complexity projects, including development and maintenance of packaging specifications and documentation.
• Participate in packaging development projects from concept through verification and transfer, supporting testing, analysis, and documentation activities to meet defined requirements, timelines, and quality standards.
• Help translate product and customer requirements into packaging and process requirements with mentorship from experienced engineers.
• Contribute as a team member on cross functional project teams (R&D, Quality, Manufacturing, Regulatory, Supply Chain), supporting packaging strategy discussions and execution.
• Execute assigned technical tasks with a strong sense of ownership and accountability, escalating risks or issues appropriately.
• Prepare and maintain technical documentation such as test protocols, reports, work instructions, and change control documentation in compliance with quality system requirements.
• Support packaging verification and validation activities, including sample preparation, coordination of testing, data collection, and basic data analysis.
• Apply fundamental engineering principles to solve packaging related problems and support continuous improvement initiatives.
• Actively develop technical knowledge in medical device packaging through training, standards review, and on the job learning.

Required Qualifications

• Bachelor s degree in Packaging Engineering, Mechanical Engineering, Biomedical Engineering, or a related technical field.
• 1 3 years of experience in packaging engineering, engineering internships/co ops, or a related engineering role;medical device, pharmaceutical, or regulated industry exposure is a plus.
• Basic understanding of medical device packaging concepts, including sterile barrier systems and non sterile packaging.
• Familiarity with relevant packaging and quality standards such as ISO 11607, ISO 13485, and packaging related ASTM or ISTA standards (coursework or practical exposure acceptable).
• Foundational knowledge of engineering statistics and data analysis;exposure to Design of Experiments (DOE) or Six Sigma concepts is a plus.
• Ability to support the development and documentation of packaging requirements and specifications with guidance.
• Familiarity with CAD and packaging design tools (e.G., CAPE, TOPS, SolidWorks, or similar) preferred.
• Strong written and verbal communication skills, with the ability to document technical work clearly and communicate effectively within a team environment.
• Strong organizational skills, attention to detail, and willingness to learn in a regulated, quality driven environment.0

Shift: [' Ability to manage competing priorities in a fast-paced environment Attention to detail Good problem-solving, organizational, analytical and critical thinking skills Good written and verbal communication skills and interpersonal relationship skills Knowledge and understanding of global regulations relevant to medical devices (Class II and/or Class III)', 'ISO 11607', 'Medical Device Design Control', 'Packaging Engineering', 'Protocols writing', 'Scientific Technical Writing']