Associate Process Development Engineer

Job Summary

Responsible for supporting the Production Services Operations Team with engineering programs, procedures, and systems that deliver products that consistently meet or exceed customer, regulatory, and company requirements. This position will support in Technical Transfer activities, improve current manufacturing processes and supporting procedures; analyze and solve problems from basic engineering principles, theories and concepts through complex and advanced problems; and prepare and execute commissioning, qualification, and validations for new equipment and computerized systems/software.

Essential Duties And Responsibilities

• Participates in and supports Technical Transfer/Process Development projects including but not limited to:
  • Create and maintain product assembly instructions.
  • Assure product and process quality by designing testing methods, testing finished goods, determining product and process capabilities, establishing standards, and confirming manufacturing processes with guidance from management.
• Validation and implementation of new or transferred manufacturing equipment, computer system/software validations.
• Conduct risk assessment on process steps and their ability to meet requirements.
• Improve manufacturing efficiency by analyzing and planning work flow, space requirements, and equipment layout.

Other Duties And Responsibilities

• Safely perform duties following NACS quality standards.
• Participate in team building, training and department communications.
• Work as a team player with management and co-workers to develop a win-win partnership through positive relationships and excellent interpersonal skills.
• Maintain a commitment to NACS’s vision and “spirit” by partnering with new and current employees by demonstrating outstanding service and integrity.

Qualifications

• Minimum of Bachelors Degree in Biomedical/Mechanical Engineering or other relevant Engineering discipline.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Ability to apply sound engineering logic to solve complex problems, assess risks, and make decision accordingly.
• Basic understanding of ISO Quality System requirements and FDA regulations.
• Problem solver able to determine root cause of technical issues and implement effective solutions in a timely manner.
• Creative thinker with ability to think ‘out of the box’ in a fast-paced entrepreneurial environment.
• Demonstrated ability to prioritize, initiate, and drive projects to completion.
• Solid knowledge of engineering fundamentals; ability to apply this knowledge to manufacturing and product.
• Strong attention to detail.
• Must be well organized.
• Must have proficiency with MS Office such as Word and Excel.
• Must have good written and verbal communication skills.

Education And/or Experience

• Bachelors Degree in Biomedical/Mechanical Engineering or other relevant Engineering discipline with preferably 1-3 years of relevant experience or 5-7 years of experience without a University Degree.

Skills

• Experience in Equipment Qualification and Computer System/Software Validation preferred.
• Ability to read, analyze, and interpret complex documentation.
• The ability to write complex documentation is required.
• Ability to effectively communicate with all levels within the company.
• Knowledge and application of mathematics, trigonometry, algebra, and statistics required.

Reasoning Abilities

• Ability to foresee changing project schedules and adjust personal assignments accordingly.
• Ability to adapt to a rapidly changing work environment and still maintain department effectiveness.

Physical Demands

• While performing duties of this job, the employee is regularly required to stand, sit, talk, walk, use hands, see, and hear.
• Drive to customer sites for meetings.
• Infrequent lifting of up to 25 pounds is required.

Work Environment

• The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
• The environment is generally clean and the noise level is moderate.
• Air is generally clean with occasional welding smoke or cleaning solvent smell.
• Production environment will include an ISO class 7 or 8 cleanroom.