Engr 2, Product Development

Bill rate is $70 ON Site 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

• Bachelors 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.