Process Development Engineer- Level II
Process Development Engineer- Level II
Posted on :
10-08-2025
Employer Active
1 Vacancy
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Yearly Salary
$ 78767 - 120000
Vacancy
1 Vacancy
Posted on :
10-08-2025
Job Description
Diasorin is a global leader in diagnostic solutions pushing the boundaries of science and technology to create cutting-edge tools that improve healthcare worldwide. With a legacy spanning over 50 years weve earned our reputation for excellence by developing innovative diagnostic assays and instruments that are trusted by healthcare providers around the world.
Our broad offering of diagnostic tests and Licensed Technology solutions made available thanks to ongoing investments in research positions us as the player with the widest range of specialty solutions in the sector and identifies us as the Diagnostics Specialist.
Why Join Diasorin
Impactful Work: When you join Diasorin you become part of a team thats dedicated to improving lives. Your contributions will directly impact patient care making a meaningful difference in the world.
Global Reach & Innovation: Our work transcends borders. Joining Diasorin means collaborating with colleagues from all over the world expanding your horizons and contributing to global healthcare solutions at the forefront of the diagnostic industry.
Diverse and Inclusive Culture: We believe in the strength of diversity and our inclusive culture reflects this commitment. We value your unique perspective and offer a supportive collaborative environment where everyone can thrive.
Join Our Team: If youre passionate about innovation diversity and making a positive impact on healthcare Diasorin is the place for you. Were looking for passionate and talented individuals who are ready to embrace new challenges and drive healthcare solutions forward.
Are you ready to be part of a dynamic team thats shaping the future of diagnostics Join Diasorin and become a catalyst for change in the world of healthcare. Apply today and be a part of our exciting journey toward a healthier more connected world. Together we can make an impact!
Job Scope
The Process Development Engineer Level II is responsible to develop automated processes that support the mass production of new and/or existing products. This role will create automated systems for mass production that integrate processes such as cutting/heat sealing lamination pick-n-place systems assembly ultrasonic welding precision filling capping label placement and packaging.
Key Responsibilities and Duties:
- Design implement and successfully scale-up automated and semi-automated solutions based upon sound engineering principles
- Lead initial equipment conceptual development and carefully balance product specifications process requirements layout complexity cost and lead-time limits.
- Collaborate closely with site and global partners to define develop and deploy automated processing technologies including equipment single-use disposables and processes
- Develop user requirements based on process quality and fitness for use in a GMP manufacturing environment. Work with vendors suppliers and internal partners to translate specific requirements into functional and design specifications
- Lead hands-on activities that support process development and process characterization including drafting procedures execution of prototype studies authoring technical reports and participating on multi-functional risk assessment teams
- Support management in business case analysis for new projects which includes inputs such as current Vs. forecast capacity standard cost analysis and ROI.
- Develop automated manufacturing processes by sourcing relevant technology and/or collaborating with automation vendors to design customized medical device manufacturing equipment to improve safety quality efficiency and cost within the manufacturing environment
- Keep abreast of meaningful technical trends and developments and incorporates them into appropriate assignments
- Lead the project management of automation development by using visual project management tools (MS Project critical path analysis etc.). Define manage and communicate project timelines and risks
- Perform Design for Manufacturing DFM Design of Experiments DOE and design/process Failure Mode and Effects Analysis (DFMEA/PFMEA)
- Collaborate with the Industrialization team for the development of validation protocols as well as its execution and reporting (for installation qualifications operational qualifications performance qualifications and process validations).
- Travel to the vendor sites as needed for equipment development FAT or to drive project timeliness.
- Collaborate with the Industrialization team and Maintenance Engineering to troubleshoot manufacturing processes/equipment to resolve production or equipment issues.
- Use CAD to design/review/update tooling and fixtures
- Responsible for performing assigned tasks in accordance with applicable Environmental Health and Safety (EHS) regulations and Company EHS policies.
- Support the companys continuous improvement efforts by supporting assignments in other areas as required.
- Responsible for enforcing all EHS policies in their span of control
- Other duties as assigned.
Education Experience and Qualifications
- Bachelors Degree Engineering degree or related experience preferred or
- 5 Years Demonstrated knowledge pharmaceutical cGMP of biotechnology products aseptic processing clean room environments required
- 3 Years Medical products GMP manufacturing experience required
- 3 Years Successful experience of leading multi-functional teams required
- 3 Years Experience with development programs
- 3 Years Experience in a variety of robotic weld applications
- 3 Years Robot and PLC simulation experience
- 3 Years Experience with field bus networks serial communication and Ethernet communication
- 3 Years Exposure to a wide variety of production machinery industrial sensors and equipment.
- 3 Years Excellent communication skills both written and verbal
- 3 Years Experience in fast-paced iterative design and manufacturing environments
- 3 Years Experience solving complex problems with little to no supervision on schedule as an individual or as a member of an integrated team
- 3 Years Ability to think critically and demonstrated troubleshooting and problem-solving skills
- 3 Years Excellent interpersonal verbal and written communication skills
- 3 Years Ability to function efficiently and independently in a fast-changing environment
- 3 Years Self-motivated and willing to accept temporary responsibilities outside of initial job description
- 5 Years Design simulate (prototyping) and implement a fully automated controls architecture to build high volume products
- 5 Years Utilize mechanical automation equipment robots PLCs motion controls and 3D vision to create entire assembly lines
- 5 Years Influence the product design in order to simplify and optimize the factory process
- 3 Years Implement reliable safety systems (ANSI / RIA15.06 OSHA) for safeguarding robots gantries conveyors and other high volume manufacturing equipment
Training and Skills
- Ability to handle and reason through complex information define problems collect data establish facts and draw objective conclusions. (High proficiency)
- Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. (High proficiency)
- Able to leverage project management & technical experience to foresight potential problems and develop contingency plans to ensure swift recovery in case of adversity. (High proficiency)
- Must be able to deconstruct a problem effectively in order to find the best and fastest solution. (High proficiency)
- Must be able to reason and communicate clearly under pressure. Fast learner and adaptable to medical device processes and regulations. (High proficiency)
Licenses and Certifications
- Lean Six Sigma Certification-IASSC preferred
Standard Working Conditions
- Candidate must be able to support occasional extended work hours to lead equipment troubleshooting/repairs when needed. Weekend or after-hours on-call support to ensure equipment is operational to support production plans. - Occasionally
Travel Requirements
- 20% Ability to travel domestic
What we offer
Salary Range
The salary range for this position is $.00 annually. The salary range for this role represents the numerous factors considered in the hiring decisions including but not limited to educations skills work experience certifications etc. Beyond base salary Diasorin offers a competitive rewards package focused on your overall well-being. We are proud to offer a comprehensive plan of health benefits retirement and financial wellbeing time off programs wellbeing support and perks. Benefits may vary by role country region union status and other employment status factors. You may also be eligible to participate in an annual incentive program. An incentive award if any depends on various factors including individual and organizational performance.
Diasorin is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin or protected veteran status and will not be discriminated against on the basis of disability.
In compliance with federal law all persons hired will be required to verify identity and eligibility to work in the United States and Canada and to complete the required employment eligibility verification document form upon hire.
Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities. If you are a US or Canada candidate and require assistance or accommodation during the application process please contact the North America Talent Acquisition Team at or 1- to request an accommodation.
The above job description is intended to describe the general content identify the essential functions and set forth the requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties responsibilities or requirements.
Diasorin reserves the right to modify or amend this job posting as needed to comply with local laws and regulations.
Please note that offers of employment at Diasorin may be contingent upon successful completion of a pre-employment background check and drug screen subject to applicable laws and regulations.
This position is not eligible for partnership with a third-party search firm vendor without expressed written consent from the Diasorin Human Resources Department.
Employment Type
Full-Time
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