POSITION SUMMARY:
This position is responsible for the transfer of product, material, and process information from development/project teams for production release. This position works with cross-functional departments to ensure all product and document information is appropriately transferred from the development/project team for new and existing products in accordance with quality, manufacturing, and customer requirements.
DUTIES AND RESPONSIBILITIES:
• Attend design reviews and other project related meetings
o Effectively communicate configuration considerations for product design
o Provide feedback on timelines and potential processing constraints
• Work with development teams to fully define the scope of configuration activities needed for a project
o Coordinate with various departments and functional groups to ensure the accuracy of information provided by development team
o Communicate documentation issues and solutions to product development team
• Generate documentation related to impact assessments and implementation preparation
o Generate Parts Maps for determination of impacts to existing product, determination of new product requirements, and assessment of the overall implementation plan.
o Prepare all documents required for Configuration (e.g. Bill of Materials (BOM), Routings, Product Specifications, etc.)
• Support departmental training program and development of new tools
• Ensure compliance to document and record control according to all MSD quality, ISO and regulatory requirements
• Specific duties may vary depending upon departmental requirements.
EXPERIENCE AND QUALIFICATIONS:
• Bachelor’s degree in Science, Engineering or related field preferred
o Additional years of relevant experience may be substituted for a degree
• Minimum of 3 years of experience working in a Manufacturing, Research & Development, Product Transfer, Quality or other related department is required
• Minimum of 1 year of experience with product commercialization including hands-on work in quality assurance, manufacturing, product transfer, and/or product development strongly preferred
• Experience in pharmaceutical, medical device or biotech industry preferred
• Experience with Change Control and/or Document Control processes is required
• Experience with ERP systems such as JD Edwards EnterpriseOne is desired
• Experience with PLM systems such as Aras Innovator is desired
KNOWLEDGE, SKILLS AND ABILITIES:
• Knowledge of product configurations and change management
• Demonstrated ability to work independently under general supervision
• Ability to identify and advocate for continuous improvement
• Logical problem solving and demonstrated ability to organize and move tasks forward in an orderly and structured fashion
• Excellent attention to detail and demonstrated ability to multi-task
• Ability to work productively in a dynamic environment with changing priorities
• Excellent oral, written communication and interpersonal skills
o Effectively communicate issues/problems and results that impact timelines for project completion
o Ability to interact professionally at multiple levels within a client-oriented organization
• Proficient in MS Office
PHYSICAL DEMANDS:
This position requires the ability to communicate and exchange information, utilize equipment necessary to perform the job, and move about the office
WORK ENVIRONMENT:
This position can be performed in a traditional or home office environment.
COMPENSATION SUMMARY:
The annual base salary for this position ranges from $78,100 to $116,200. This salary range represents a general guideline as MSD considers other factors when presenting an offer of employment, such as scope and responsibilities of the position, external market factors, and the candidate’s knowledge, skills, abilities, education and experience. Employees may qualify for a discretionary or non-discretionary bonus in addition to their base salary. These annual bonuses are intended to recognize individual performance and enable employees to benefit from the Company's overall success.
BENEFITS SUMMARY:
At MSD, we offer a comprehensive benefits package to support our employees' well-being and financial security. In addition to competitive salaries, our benefits include medical, dental, and vision coverage, along with prescription benefits. We provide a 401(k) plan with company matching, flexible spending accounts, and company-paid short- and long-term disability insurance as well as group life and accidental death and dismemberment insurance. Our offerings also encompass paid vacation, paid sick leave, paid holidays, and paid parental leave, along with an employee assistance program. Additional voluntary perks include a fitness club membership contribution, pet insurance, identity theft protection, home and auto insurance discounts, and optional supplemental life insurance.
EEO/AA STATEMENT:
MSD is an Equal Opportunity/Affirmative Action Employer. We are committed to fostering a diverse and inclusive workplace where all individuals are treated with respect and dignity. We welcome applications from all qualified candidates, making employment decisions without regard to race, color, religion, creed, sex, sexual orientation, gender identity, genetic information, marital status, national origin, age, protected veteran status, pregnancy, disability status, or any other protected characteristic. For our full EEO/AA and Pay Transparency statement, please click on the following link: mesoscale.com .
Meso Scale Diagnostics uses E-Verify to validate the work eligibility of candidates.
Requirements
Must-haves
Attend design reviews and other project related meetings
o Effectively communicate configuration considerations for product design
o Provide feedback on timelines and potential processing constraints
Work with development teams to fully define the scope of configuration activities needed for a project
o Coordinate with various departments and functional groups to ensure the accuracy of information provided by development team
o Communicate documentation issues and solutions to product development team
Generate documentation related to impact assessments and implementation preparation
o Generate Parts Maps for determination of impacts to existing product, determination of new product requirements, and assessment of the overall implementation plan.
o Prepare all documents required for Configuration (e.g. Bill of Materials (BOM), Routings, Product Specifications, etc.)
Support departmental training program and development of new tools
Ensure compliance to document and record control according to all MSD quality, ISO and regulatory requirements
Specific duties may vary depending upon departmental requirements.
o Additional years of relevant experience may be substituted for a degree
Minimum of 3 years of experience working in a Manufacturing, Research & Development, Product Transfer, Quality or other related department is required
Experience with Change Control and/or Document Control processes is required
Experience with ERP systems such as JD Edwards EnterpriseOne is desired
Experience with PLM systems such as Aras Innovator is desired
Knowledge of product configurations and change management
Demonstrated ability to work independently under general supervision
Ability to identify and advocate for continuous improvement
Logical problem solving and demonstrated ability to organize and move tasks forward in an orderly and structured fashion
Nice-to-haves
Bachelor’s degree in Science, Engineering or related field preferred
Minimum of 1 year of experience with product commercialization including hands-on work in quality assurance, manufacturing, product transfer, and/or product development strongly preferred
Experience in pharmaceutical, medical device or biotech industry preferred
Application prep
Use the role’s language and application details while tailoring your materials.