Director – Instrument Manufacturing Engineering

Director – Instrument Manufacturing Engineering

Requirements

• Minimum ten (10) years’ experience in Program Management
• Bachelor’s Degree is required in Engineering
• Track record of success in leading and managing engineering projects
• Experience in life sciences, biotechnology medical device or diagnostic industries
• Experience in managing projects to meet changing regulatory requirements is preferred
• Experience working in Design Control, Change Management, ISO and FDA environment
• Understanding of regulations, standards and guidelines related to IVD, and/or medical devices and quality systems including 21 CFR, IVDD, IVDR, ISO14971, ISO13485, etc.
• Experience managing external suppliers, vendors and contractors
• Effective verbal, written and presentation skills required
• Ability to travel up to 10%

Responsibilities

• Provide support for supplier selection, qualification and resolution of quality issues, including the definition of incorporation of critical feature inspection and test points in the manufacturing and QC process.
• Accountable for engineering support and technology aspects of BDB Instrumented manufacturing processes required to meet manufacturing output, efficiency, quality, and cost objectives.
• Works with BDB Instrument Plant Managers world-wide to provide engineering support and systems to meet production goals.
• Works with corporate level functions driving cross business efforts in Electro Mechanical Instrumentation (EMI) areas of manufacturing, system and sub-assembly testing, best practices with NPI, and the implementation of cost-reduction, re-design and PPV efforts.
• Maintains connections with industry and professional organizations. Stays informed of and sources new technology as required to meet manufacturing objectives.
• Leverages process and system uniformity across multiple manufacturing sites.
• Responsible for development and implementation of a manufacturing engineering strategy and programs to the support BDB manufacturing plants and operations.
• Participate on the Executive Sustaining Governance Committee meetings, providing strategic guidance and recommendations as it pertains to decisions on Sustaining Engineering Process and Programs or Projects.
• Employ disciplined value engineering processes to gather information, identify alternatives, analyze the cost/benefit, and select the best opportunities to execute.
• Ensures that the portfolio of Sustaining Engineering Projects is prioritized and executed in accordance with overall business objectives.
• Accountable for driving CI/PPV/Re-design elements while working collaboratively with plant leadership, supply chain, quality, regulatory, R&D and business/platform leadership.
• Accountable to establish a Product Lifecycle Engineering governance body and process to effectively manage the portfolio for cost effective product end of life.
• Actively participates in new project proposal review, valuation, classification and platform prioritization.
• Partners with NPI team and Production Manager Teams to be efficiently implement new products and acquisitions into manufacturing internally or to transfer to a CM in a global manufacturing environment.
• Works closely with R&D developing effective technology transfer processes and plans for new and existing instrument platforms. Implements manufacturing systems for effective new product transfer per key business objectives.
• Identify and resolve gaps in key competencies, leadership, skillsets and succession depth to meet business need.
• Lead manufacturing engineering to provide technical product line support to ensure quality, delivery, and cost goals. Identify and drive implementation of continuous improvement projects such as, first pass yield, cycle time reduction, product reliability, customer complaints and cost reduction.
• Develops and maintains capital and financial budgets for assigned departments.
• Responsible for establishing overall strategy and execution performance levels for Operations engineering leadership.
• Assess project resource skill, loading, and time allocation requirements and assure the appropriate allocation of a broad engineering resource skill base across multiple plants.
• Responsible for developing and maintaining compliance with the Quality system, provide technical support for Material Review Board (MRB) and CAPA review.
• Develop technical depth for problem resolution, manufacturing processes, lean manufacturing, and business processes (ECOs, MRB, CAPA and ERP applications).
• Ensure safety program meets EH&S requirements.
• Familiar with GMP’s, ISO requirements, the IVD Directive, CE marking, Six Sigma and LEAN principles.

Preferred Qualifications

• Postgraduate degree (e.g. MBA or Masters or PhD) is preferred
• Black Belt or Design For Six Sigma and PMP are also preferred
• Experience in managing projects to meet changing regulatory requirements is preferred