Manufacturing Engineer II
March 2, 2022
This position is integral to both the contract manufacturing and product development sides of the business, and is focused on the development, implementation, and validation of production processes. This is a dynamic and challenging role with high growth potential supported by an experienced leadership team.
Essential Duties and Responsibilities:
- Develops assembly and product inspection processes
- Designs assembly fixtures and test equipment
- Drafts the initial manufacturing work instructions and refines them over time
- Identifies critical unit operations and implements solutions to maintain control
- Prepares production documentation and prepares DCR’s for release
- Creates detailed records including Device History Records for device production
- Specifies manufacturing equipment
- Completes IQ, OQ and PQ process validations
- Contribute to Risk Management efforts including Process Failure Mode and Effect Analysis
- Supports New Product Introduction (NPI) and Design Transfer activities
- Assists with build planning and inventory management
- Coordinates with outside suppliers to ensure delivery of supplies or services
- Participates in Material Review Board activities and dispositions of inventory
Education, Experience, Skills and Knowledge:
- Bachelor’s Degree in Engineering or Technical Field required
- Customer focus with excellent written and oral communications skills required
- Minimum 3 years experience in a Technical Role; Medical Device experience required
- Knowledge of statistical methods, process validation, and process controls required
- Familiarity with 21 CFR 820 and ISO 13485:2016 preferred
- Experience in disposable medical device manufacturing preferred
- Proficiency in SolidWorks preferred
The above statements are intended to describe the general nature and level of work being performed by people assigned to do this job. The above is not intended to be an exhaustive list of all responsibilities and duties required.
$62,000 to $85,000 (25th percentile/90th percentile, PayScale data); Bonus eligible depending on achieving company performance targets
This position will be eligible to enroll in benefits including health, dental and vision programs as well as AD&D and Long-Term Disability Insurance, 401(k). Position will accrue 15 PTO days per year and 1 additional day for each year of service (up to 25 days).
Apply to: email@example.com
EQUAL OPPORTUNITY EMPLOYER
Meddux Development Corporation is an equal opportunity employer and considers all applicants for employment without regard to race, color, religion, national origin, ancestry, sex, sexual orientation, gender identity, transgender status, pregnancy or a condition related to pregnancy, age (as defined by law), disability, military or veteran status, genetic information, or based on any individual’s status in any group or class protected by applicable federal, state, or local law. Meddux provides reasonable accommodations to qualified individuals with disabilities in accordance with the Americans with Disabilities Act and applicable state and local law. If you require an accommodation in the application process, please contact Human Resources.