Senior Manufacturing Manager, Instruments
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Job Location:
Austin, TX - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
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
Senior Manufacturing Manager Instruments - 2 leads Manufacturing operation of moderate to high span of control and complexity in the execution of a diverse instrument product portfolio serving the in-vitro diagnostic and research markets.
This position is responsible for Instrument Manufacturing product realization leading to the production of safe effective and compliant IVD and/or RUO instrumentation. Accountable for financial performance of Instrument Manufacturing organization adherence to all requirements of cGMP as applicable management of direct reports and their staff and execution of business plans.
Senior Manufacturing Manager Instruments - 2 leads Manufacturing operation of moderate to high span of control and complexity in the execution of a diverse instrument product portfolio serving the in-vitro diagnostic and research markets.
This position is responsible for Instrument Manufacturing product realization leading to the production of safe effective and compliant IVD and/or RUO instrumentation. Accountable for financial performance of Instrument Manufacturing organization adherence to all requirements of cGMP as applicable management of direct reports and their staff and execution of business plans.
Responsibilities and Duties
- Provide leadership and direct management of supervisory and direct employees in the Instrument Manufacturing.
- Develop and execute plans and resource requirements (people equipment infrastructure) to ensure fulfillment of production demand per business plan
- Ensure effective and compliant work instructions training requirements equipment management and facilities.
- Deliver design transfer requirements readiness and execution in partnership with Manufacturing Engineering for new product introduction and product changes.
- Support planning and execution of equipment and process validations in partnership with Manufacturing Engineering
- Ensure accurate costing through effective management of make item BOMs resource routing lot size standards and variances; anticipate forward looking cost change impacts relative to operational plans
- Plan and implement business process optimization and lean initiatives to eliminate waste and enhance control responsiveness and flexibility
- Identify and implement continuous improvement initiatives targeting quality compliance safety efficiency and cost.
- Participate in planning and delivery of global business process integration improvement and harmonization initiatives.
- Assist in design and implementation of infrastructure improvements affecting Manufacturing.
- Ensure effective development monitoring and reporting of performance metrics.
- Collect analyze and trend data and present data/findings/recommendations
- Effectively hire train develop and evaluate staff in alignment with business needs. Take corrective action as necessary on a timely basis and in accordance with Company policy. Ensure compliance with current federal state and local regulations in consultation with Human Resources as appropriate.
- Ensure accuracy of operation specific job descriptions; ensure personnel awareness of job responsibilities and job performance connection to customer.
- Ensure applicable standard operating procedure and task-specific training is timely and effective for department personnel.
- Drive annual departmental capital headcount and expense budgeting requirements.
- Authorize section expenditures and maintain accountability to budget integrity and financial performance.
- Participate in development and drive execution to Manufacturing MBOs
- Effectively engage with cross-functional operations to support the business
- Ensure effective prioritization investigation and resolution of findings impacting Instrument Manufacturing identified through audits non-conformances corrective/preventative actions or customer complaint escalation.
- Ensure operational compliance with the Luminex Quality System including FDA and ISO 13485 requirements as applicable.
- Ensure operational adherence to safety and waste disposal requirements.
- Other duties as assigned.
Education Experience and Qualifications
- Bachelors Degree Bachelor of Science degree in Mechanical or Electrical Engineering related discipline or relevant scientific degree required
- 10 Years Relevant experience in a electromechanical assembly manufacturing environment required
- 8 Years Relevant Manufacturing Operations Leadership experience required
- 5 Years Relevant experience in relevant ISO 13485 and/or FDA regulated setting preferred
Training and Skills
- Thorough knowledge of ISO 13485 and FDA Quality System requirements as applicable
- Thorough knowledge of Design Control requirements as defined by the FDA Quality System guidelines as applicable
- Applied knowledge of equipment process test method and software validations as required by FDA Quality System guidelines as applicable
- Proven proficiency in promoting safety culture
- Proficiency in Manufacturing Resource Planning and Manufacturing Execution Systems such as Oracle or SAP preferred
- Proficiency in Product Lifecycle Management tools preferred
- Proven results through application of Lean Manufacturing principles and applied knowledge of statistical design of experiments preferred
- Proficiency in statistical process control preferred
- Proficiency in data analysis tools problem solving tools and technical writing
- Applied knowledge of optical designs and calibration
- Proficiency in Geometric Dimensioning and Tolerancing
Standard Working Conditions
- Standing - Frequently
- Stooping - Occasionally
- Bending - Occasionally
- Climbing - Rarely
- Sitting - Frequently
- Kneeling - Rarely
- Lifting of at least 40lbs - Occasionally
Travel Requirements
- Up to 10% travel is estimated
Our people are passionate about what they do the product they sell and the customers they serve. If youre looking for an opportunity to be a part of a work family that values collaboration innovation and dedication were the right company for you.
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.
Required Experience:
Manager
Key Skills
- Lean Manufacturing
- Six Sigma
- Continuous Improvement
- ISO 9001
- Lean Six Sigma
- Management Experience
- Manufacturing & Controls
- 5S
- Manufacturing Management
- Kaizen
- Chemistry
- Manufacturing
About Company
Luminex Licensed Technology: Diasorin provides innovative xMAP® Technology solutions for fast, reliable answers in research, impacting daily patient health outcomes.
