Engineering Structures Jobs in Sunrise, FL

Position- Chief Financial Officer

Location- Fort Lauderdale, FL

Summary

As a key member of the Executive Management team, the Chief Financial Officer will report to the CEO and will have direct reporting requirements to the Board of Directors, and assume a strategic and operational role in the overall management of the company. The CFO will have primary day-to-day responsibility for planning, implementing, managing, and controlling all financial-related activities of the company as well as a few operational activities related to the growth of the company. This will include direct responsibility for accounting, finance, accounts payable, payroll, forecasting, strategic planning, revenue cycle, insurance, M&A, investor relationships and institutional financing.

Duties/Responsibilities

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Drive the company’s financial planning
• Determine active growth strategies while considering cash and liquidity risks
• Control and evaluate the organization’s fundraising plans and capital structure
• Ensure cash flow is appropriate for the organization’s operations
• Lead and execute M&A activities
• Oversee medical billing and accounts receivable functions
• Assist the lease negotiations and lease management activities
• Ensure compliance with the law and company’s policies
• Interact with private equity sponsor, Webster Capital, on a weekly basis
• Implement policies, procedures and processes as deemed appropriate by senior leadership team
• Prepare and present monthly financial budgeting reports; monthly profit and loss by division, forecast vs. budget by division and weekly cash flow by division
• Deliver presentations and serve as a main point of contact to banks, lenders, financial partners, institutions, investors, public auditors and officials
• Remain current on audit best practices; and state, federal and local law regarding company operations
• Create and establish yearly financial objectives that align with the company’s plan for growth and expansion
• Manage the financial and reporting systems of the organization
• Recruit, interview and hire finance, accounting and payroll staff as required
• Participate in pivotal decisions as they relate to strategic initiatives and operational models
• Interact with and bring department into line with Board of Directors plans initiatives and recommendations
• Implement policies, procedures and processes as deemed appropriate by senior leadership team
• Prepare and present monthly financial budgeting reports; monthly profit and loss by region, forecast vs. budget by division and weekly cash flow by division
• Review and analyze monthly financial results and provide recommendations
• Identify, develop and execute analysis of business initiatives, product launches and /or new service offerings
• Develop and maintain monthly operating budget and annual company operating budget
• Oversee the preparation of timely filing of all local, state, and federal tax returns
• Oversee and assist with annual audit process
• Oversee the month end close process, constantly reviewing procedures while eliminating inefficiencies
• Oversee preparation of monthly, quarterly and annual financial statements
• Review all month-end closing activities including general ledger accounts, balance sheet accounts and overhead cost allocation
• Serve as a key point of contact for external auditors; Manage preparation and support of all external audits
• Manage cash flow planning process and ensure funds availability
• Explore new investment opportunities and provide recommendations on potential returns and risks
• Maintain outstanding banking relationships and strategic alliances with vendors and business partners
• Utilize forward-looking models and activity-based analyses to provide financial insight into the organization’s plans and operating budgets
• Deliver presentations and serve as a main point of contact to banks, lenders, financial partners, institutions, investors, auditors and officials
• Remain current on audit best practices; and state, federal and local law regarding company operations

Competencies:

• Strong presence and excellent communication skills both “oral and written” to lead and motivate employees, work directly with key customers
• Relates well to a wide variety of diverse styles, types, and classes; open to differences. Builds diverse networks; quick to find common ground; treats differences fairly and equitably; treats everyone as a preferred customer
• Is skilled at getting individuals, teams, and an entire organization to perform at a higher level and to embrace change; negotiates skillfully to achieve a fair outcome or promote a common cause; communicates a compelling vision and is committed to what needs to be done; inspires others; builds motivated, high performing teams; understands what motivates different people
• A leader who leads by example and is capable of inspiring dedicated professionals at all levels. A leader with unquestionable ethics and integrity and whom others want to follow and respect
• Dynamic, forward-thinking leader who is also practical and results-oriented
• Action-oriented and entrepreneurial, decisive and able to make timely decisions in a fast paced, business environment
• A strong change agent who is a good listener and respectful of others
• Intelligent, creative and strategic, with tremendous energy and drive, eager to make significant impact across the organization
• Multi-dimensional thinker who operates not only on the basis of important past experience, but in light of new approaches and development that occur in a changing and competitive marketplace.

Qualification

• Master's degree in Business Administration, Accounting, or Finance required.
• Certified Public Accountant designation preferred.
• Eight to ten years of experience in financial management required.

Travel required

• Up to 25% - 50% travel, by car to assigned local Centers that we currently provide services in or will be providing services in the future, based on the region

Industrial Engineer

We are seeking a candidate with a background in Industrial Engineering and Operational Risk to drive process transformation within a regulated environment.

Bachelor's Degree in Industrial Engineering (REQUIRED)

Key Responsibilities

• Project Leadership: Manage end-to-end execution under strict timelines while ensuring full regulatory compliance.
• Process Innovation: Lead transformation initiatives to optimize control effectiveness and monitoring strategies, quantify risk mitigation and drive measurable business impact (ROI/Cost Savings).
• Data Analysis: Use quantitative analysis and structured problem-solving to identify risks and trends.
• AI Adoption: Integrate AI-enabled tools to enhance operational efficiency and decision-making.
• Stakeholder Management: Build leadership-ready presentations and clearly communicate insights across all organizational levels.

Required Qualifications

• Education: Bachelor's Degree in Industrial Engineering (REQUIRED).
• Experience: 2+ years in experience in Project Management, Process Engineering, or Operational Risk Preferred
• Environment: Nice to have proven ability to navigate regulated environments(Financial Services preferred).
• Analytical Power: Mastery of Excel (including complex modeling, macros, and trend forecasting). SQL or Tableau experience is a significant plus. Advanced proficiency in Excel for financial/risk modeling (not just PivotTables)
• Strategic Communication: Proven track record of influencing cross-functional teams and managing stakeholder expectations without direct authority.
• Financial Literacy: Ability to quantify the business impact (ROI, Cost-Benefit) of process changes and risk mitigation strategies.
• PowerPoint for storytelling with data. (Executive-level deck building).
• Soft Skills: Superior analytical, communication, and interpersonal skills.

Preferred Experience

• Risk Management: Operational risk identification, mitigation, and monitoring.
• Frameworks: Experience with process governance, risk assessments, or control frameworks.
• Technology: Hands-on experience adopting or working alongside AI solutions.

Why Join Us?

• Drive high-impact enterprise-level risk and innovation strategies.
• Work at the intersection of Industrial Engineering, Risk, and AI.
• High visibility with cross-functional leadership and global stakeholders.

#IndustrialEngineering #ProcessImprovement #ProjectManagement #OperationalRisk #Hiring

We are seeking a skilled Chemical Engineer to design, analyze, and optimize pharmaceutical manufacturing processes. The role involves leading process improvement and development projects, resolving complex technical and operational challenges, and ensuring compliance with Good Manufacturing Practices (GMP), quality standards, and regulatory requirements. The ideal candidate will have strong technical expertise, project management experience, and a continuous improvement mindset.

Shift / Working Hours

• Hours: 8:00 AM – 5:00 PM Mon- Fri

Key Responsibilities

• Analyze, design, and optimize pharmaceutical manufacturing processes (e.g., formulation, mixing, granulation, coating, sterilization)
• Lead process improvement and development projects from concept through implementation
• Apply structured problem-solving methodologies (Root Cause Analysis, 5 Whys, Fishbone, FMEA) to address deviations and operational issues
• Drive process improvement initiatives focused on yield, efficiency, robustness, and scalability
• Collaborate with Production, Quality, Validation, Engineering, Maintenance, and R&D teams
• Ensure all process changes comply with GMP, regulatory requirements, and quality standards
• Develop, review, and maintain process documentation, SOPs, batch records, and technical reports
• Support process validation, revalidation, and technology transfer activities
• Analyze process data and KPIs to drive continuous improvement and risk reduction
• Lead or support CAPA investigations related to process deviations, non-conformances, and OOS results
• Participate in internal and external audits (FDA, EMA, local authorities)
• Train manufacturing and technical personnel on process changes and best practices

Required & Preferred Qualifications

Education

• Bachelor's degree in Chemical Engineering
• 5–10 years of experience in chemical engineering, process improvement, or pharmaceutical manufacturing
• Proven experience in process development and project execution
• Strong technical problem-solving and root cause analysis skills
• Experience supporting validation and regulatory inspections preferred

Technical Knowledge

• Pharmaceutical manufacturing processes and unit operations
• GMP / cGMP, FDA, EMA regulations
• Process validation, scale-up, and technology transfer
• Risk management tools (FMEA, HACCP)
• Statistical analysis and process capability (Cp, Cpk)
• Process data analysis tools and advanced Excel

Apply now

Molding Process Engineer

Job Description

About Company

At Ennovi we harness the power of two megatrends - electrification and AI - to help industries innovate at speed, operate smarter, and achieve sustainable growth. By combining these transformative forces with our global reach and best talent, we empower our customers to lead their markets and drive sustainable progress.

From automotive to aerospace, consumer electronics, data storage, industrial, and medical markets, we help our customers achieve these megatrends by creating smarter, safer, and more sustainable solutions.

We excel in developing high-performance, custom solutions that meet diverse technical needs, solve unique challenges, optimize performance, and adapt to evolving market demands.

Our mission is to get customers to the future faster, from anywhere. Headquartered in Singapore, ENNOVI has a global presence across North America, Europe, SEA and China, where all its activities are socially responsible, with minimal environmental impact. Learn more at Join Us

At Ennovi, we envision a future of electrification and innovation and strive to create an inspiring workplace where our employees are integral to shaping that future. We offer a dynamic, collaborative and inclusive culture that encourages continuous learning, professional growth, and a sense of purpose. As a part of the Ennovi team, employees experience the excitement of being at the forefront of cutting-edge technologies and contributing to a sustainable future.

Our commitment to the transformation is epitomized by our five pillars: Speed, Innovation, Best Talent, Global Reach, and Sustainability. This entails navigating exponential market changes through agile structures, fostering innovation across all aspects of our business, strategically expanding our global footprint, championing sustainability initiatives and nurturing a winning team.

Privacy Policy

Ennovi is an equal opportunity employer in conformance with all applicable laws and regulations to individuals who are qualified to perform job requirements. The Company administers its personnel policies, programs, and practices in a non-discriminatory manner in all aspects of the employment relationship, including recruitment, hiring, work assignment, promotion, transfer, termination, wage and salary administration, and selection for training.

By applying to this job posting, you agree with and acknowledge our privacy policy.

Job Summary

We are seeking a Molding Process Engineer to join our team in the Medical Business.

The Molding Process Engineer reports directly to the Engineering Manager and will be responsible for the support of all internal moulding activities that include product development, validation, qualification and implementation of processes, methods and equipment. Strong process development capabilities are essential.

Ennovi Medical is your end-to-end customized solutions partner, empowering OEMs to harness AI-driven technologies and accelerate innovation for medical devices.

Main Responsibilities

• Develop, validate, and optimize injection molding processes for new and existing medical products.
• Collaborate with tooling, quality, and production teams to ensure robust mold designs and process capability.
• Lead root cause analysis and corrective actions for molding-related defects and process deviations.
• Support mold qualifications, including IQ/OQ/PQ protocols and documentation.
• Monitor and analyse process data to drive continuous improvement and reduce scrap and downtime.
• Specify and implement process controls to enhance molding performance.
• Maintain compliance with GMP, ISO 13485, and FDA requirements.
• Train operators and technicians on molding best practices and troubleshooting techniques.
• Participate in cross-functional teams for new product introductions and engineering changes.

Qualifications & Skills

• Bachelor's degree in mechanical, Industrial, or Plastics Engineering or equivalent (5 years in relevant experience)
• Minimum of 3 years of experience within a Plastics/Polymer processing
• Experience with functioning in a highly regulated environment
• Strong understanding of Polymer technology and test methods
• Strong written and verbal communication skills
• Demonstrated experience in manufacturing medical devices using various manufacturing technologies
• Excellent process development capabilities
• Experience and proficient with Data Analysis, Root Cause Analysis and Statistical Method Application.
• Six Sigma Greenbelt and Lean Process Background
• Experience working with insert molding
• RJG Master Molder certification or equivalent.
• Experience with automation and robotics in molding operations.
• Familiarity with ERP and MES systems.

Job Title : Nuclear Engineer (Naval Reactors Engineer) Category / Component : Officer • Active Overview Design, regulate, and oversee the Navy's nuclear propulsion program, including reactor design, fleet operations, and eventual defueling and decommissioning of nuclear powered ships and submarines from Naval Reactors Headquarters and associated Department of Energy laboratories and shipyards.

Key Responsibilities Provide technical direction in areas such as reactor and fluid systems design, reactor physics, materials development, component design for steam generators, pumps, and valves, instrumentation and control for reactor and propulsion plants, testing and quality control, radiation shielding, and chemistry and radiological controls; review designs and analyses from laboratories, shipyards, and industry partners; coordinate with fleet units to ensure safe and reliable nuclear plant operation.

What to Expect Assume significant technical responsibility early in your career as part of a lean headquarters staff; work primarily in an analytical and oversight role rather than operating plants at sea; balance long term engineering projects with time sensitive fleet and shipyard issues; frequent coordination with senior civilian engineers, naval officers, and technical teams; high expectations for attention to detail, judgment, and written and oral communication.

Work Environment Work mainly at Naval Reactors Headquarters in the Washington, District of Columbia area with regular engagement with Department of Energy laboratories, nuclear training sites, shipyards, and nuclear powered ships and submarines; office based work that includes document reviews, technical meetings, inspections, and site visits rather than day to day shipboard watchstanding.

Pathways, Training & Advancement Officer commissioning through programs such as Officer Candidate School or the Nuclear Propulsion Officer Candidate program followed by a structured technical qualification program at Naval Reactors; rotational exposure to laboratories, prototypes, shipyards, and fleet support issues; progressive responsibility leading projects and becoming a subject matter expert, with opportunities for professional military education and advanced graduate study in technical fields.

Entry through the Nuclear Propulsion Officer Candidate program for qualified college students and recent graduates, or selection via Officer Candidate School for those who already hold qualifying degrees; all applicants must meet Nuclear Propulsion Program academic and technical screening standards in addition to general officer commissioning requirements.

Qualifications All Navy jobs require meeting general enlistment or commissioning standards, which typically include: Eligibility to serve in the United States Navy, which may involve United States citizenship or other legal residency and work status, depending on the program and current law and policy A high school diploma or equivalent for enlisted positions, and a bachelor's or qualifying professional degree for officer positions Meeting age limits that vary by program and are set in law and Navy policy.

Some communities have more restrictive age ranges Meeting medical, vision, and dental standards, including body composition and physical fitness requirements, with some jobs requiring more demanding standards Meeting character and conduct standards, including background screening Achieving required test scores for your program, such as the Armed Services Vocational Aptitude Battery for enlisted roles or officer qualification tests for officer programs Eligibility for a security clearance when required for your rating or designator Additional qualifications can include specific skills, education, licensure, or experience that are unique to a job or community and will be reviewed with you by a recruiter.

Additional qualifications for this job may include: Completion of a rigorous technical degree in engineering, physics, mathematics, or a closely related field that includes strong backgrounds in calculus and physics; outstanding academic record, particularly in technical coursework; United States citizenship and eligibility for a high level security clearance; strong technical aptitude and comfort with detailed analytical work.

Education Education benefits are available through standard Navy programs such as Tuition Assistance, the Post-9/11 GI Bill, ACE-recommended college credit for Navy training, Navy COOL-funded certifications, USMAP apprenticeships, and other Navy College Program opportunities.

Specific options depend on the Sailor's status, training, and current Navy policy.

Pay, Benefits & Service Pay, benefits, and service commitments follow standard Navy Active and/or Reserve policies for this type of role, including basic pay, allowances when eligible, health coverage, and retirement options.

Exact entitlements, special pays, and service obligations depend on program, component, years of service, and current law and Navy guidance.

Incentives Incentives such as bonuses, special pays, and loan repayment may be available at times for specific ratings or communities, but they change frequently and cannot be guaranteed.

Applicants must confirm current incentives and eligibility with an official Navy recruiter or authoritative Navy source.

Notes and Disclaimers This description is a general overview of typical duties, training, and opportunities in this community.

It does not replace official Navy instructions, policies, or contracts and does not guarantee specific assignments, training, incentives, or outcomes.

Actual opportunities depend on Navy needs, individual performance, screening results, and current law and policy.

For more than 20 years MAN Engines & Components is the primary importer and service representative of MAN engines, components and parts with responsibility for North, Central and South America. The American subsidiary of MAN Truck & Bus AG has a long-term experience of packaging MAN "high speed" marine engines for major boat builders and its distributors. Together with its 65 dealers it provides an extensive service network for MAN Marine Diesel engines in its territory.

MAN Engines & Components is also the exclusive importer of industrial diesel and gas engines for construction equipment, agricultural machinery and power generation including CHP (combined heat power) application.

Additionally bus and heavy-duty truck axles are being assembled and provided to the North American market. High quality chassis components and transfer cases are integral part of the product portfolio.

Title: Manager Trade and Compliance Logistics

************This is NOT a remote position, 5 days in-office******************

Candidate must be able to commute to the Pompano Beach location

Summary:

The Manager Trade Compliance and Logistics ensures the company complies with all applicable import and export laws and regulations while supporting business operations. The initial priority for this role is to evaluate and address the company's import tariff exposure, ensuring full compliance while minimizing financial and operational impacts.

Roles and Responsibilities:

• Ensure compliance with all import and export laws and regulations (CBP, EAR, OFAC, and other participating government agencies).
• Monitor, interpret and communicate changes in trade regulations as well as assessing their impact on the business (duties, tariffs, trade agreements).
• Lead the process to obtain and maintain the Customs Trade Partnership Against Terrorism (CTPAT) Certification for the company.
• Liaise with customs authorities, governmental agencies, and external partners.
• Develop, implement, and maintain trade compliance policies and procedures aligned with national regulations, international requirements, and corporate standards.
• Design and deliver training programs to educate employees on import and export compliance requirements.
• Collaborate cross-functionally with procurement, logistics, supply chain, sales administration, and finance to coordinate import and export activities and resolve import and export customs issues.
• Conduct internal audits of import and export transactions and oversight of customs brokers and freight forwarders.
• Screen business partner for integrity and compliance (restricted party and sanctions lists) and perform due diligence checks.
• Support and review the classification of goods for import and export (HTS, ECCN)
• Prepare and maintain documentation required for duty drawback claims.
• Analyze and report logistic costs and import and export data (ACE, AES)
• Support negotiating contracts with carriers, freight forwarders, and customs brokers.

Requirements:

• The ability to conduct independent research and interpret complex regulations to provide clear, actionable guidance is essential for success in this role.
• Bachelor's degree in International Business, International Trade or related field.
• 4-5 Years of professional experience in import/export compliance, customs operations, or logistics management
• U.S. Licensed Customs Broker – preferred
• NCBFAA Certified Export Specialist – preferred
• Strong analytical and problem-solving skills
• High attention to detail and strong organizational skills.
• Excellent communication skills for working with internal teams and government agencies.
• German and/or Spanish language skills are a plus

Benefits:

• Annual base salary plus performance bonus
• Vacation days and sick leave
• Child leave
• Health insurance coverage with HSA Contribution
• Dental & Vision Benefits
• Life, AD&D and STD/LTD insurance
• 401(k) Plan & 401(k) Match
• Wellness Benefit
• Up to 14 Holidays
• Vehicle Leasing program

Akkodis is seeking a HVAC Development Engineer for a Direct Hire job with a client in Fort Lauderdale, FL.

Salary Range: $87K/Annum to $92K/Annum; The salary may be negotiable based on experience, education, geographic location, and other factors.

HVAC Development Engineer:

• Establish validation Test Plans for HVAC units, Specifications, Reliability testing and perform the tests in lab per the established plan
• Support build of all IPM and FARR simulation models for the new and legacy products by providing necessary inputs
• Raise Engineering Change Requests (ECRs) and track their progress
• Create component specifications to support resourcing and procurement
• UL & AHRI Regulatory knowledge and application to products testing and specification (AHRI, UL, ETL)

Desired Qualifications:

• Bachelor's degree in Engineering disciplines (Mechanical / Mechatronics preferred)
• Experience with technical risk assessment tools (e.g., FMEA, DRBFM)
• Strong organizational & interpersonal skills
• Excellent oral and written communication skills
• Test prototypes and write reports to document results
• Develop specifications, detailing and assembly drawings for products and equipment

If you are interested in this role, then please click APPLY NOW. For other opportunities available at Akkodis, or any questions, feel free to contact me at (61 or ().

Equal Opportunity Employer/Veterans/Disabled

Benefits offerings include but are not limited to:

• 401(k) with match
• Medical insurance
• Dental Insurance
• Vision assistance
• Paid Time Off

To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

· The California Fair Chance Act

· Los Angeles City Fair Chance Ordinance

· Los Angeles County Fair Chance Ordinance for Employers

· San Francisco Fair Chance Ordinance

Company Description:

A world leader in water treatment solutions, IDE specializes in the development, engineering, construction and operation of desalination, water reuse, and industrial water treatment plants.

Duties and Responsibilities (at a minimum):

• Provide process engineering leadership and technical support to Operations and Maintenance, including training, troubleshooting, and optimization of plant performance.
• Provide process set points and operating recommendations and coordinate implementation with the Plant Manager and Chief Operator to optimize plant operation.
• Prepare and provide appropriate reports for the Plant Manager
• Achieving and stabilizing the required quality parameters of the final product water supplied to the customer
• Continuous monitoring (online) on the process and the production performance of the plant, using the control room monitors, online reports and online alarms
• Monitoring the performance of the membranes by using periodic and continuous reports of short and long-term trends
• Daily, weekly and monthly reports to the various authorities
• Developing process monitoring tools, including daily, weekly and monthly process performance reports. Identify trends and problems, and defining the right solution
• Managing weekly meetings to identify process problems and defining solutions
• Availability 24 hours a day 7 days a week to provide immediate instructions to the control room
• Participate in the review, formulation and implementation of an Annual Operations Plan
• Participate in the review, formulation, implementation and achievement of an 'Annual Budget' and ensure its consistency with the 'Annual O&M budget plan'
• Participate in the provision of an accurate and representative progress report against the achievements of the 'Annual Operations Plan'
• Participate in the selection and recruitment procedure where appropriate
• Demonstrate commitment to the principles of 'Continuous Improvement'
• Participate in the identification and implementation of initiatives that will result in performance improvements
• Participate in the continuous development of systems, procedures and where appropriate 'Standard Operations', for all recurring activities
• Participate in the development and publication of statistical data and reports to the plant owners and the company
• Keep abreast of changes in the process and make recommendations as appropriate
• Ensure that all operations in your work are carried out in compliance with current Health and Safety Regulations.
• To ensure that all \"Waste Disposal\" procedures are carried out in accordance with current statutory requirements
• Generate work instructions and operating guidance for new or modified processes and distribute to the Plant Manager, Maintenance Manager, and Chief Operator.
• To undertake other such duties which may arise from time to time and are consistent with the nature of the position of your responsibility.

Reporting Line: Directly to the Plant Manager

Personal Attributes:

• Effective communication skills both written and spoken
• Good analytical and problem-solving skills
• Work successfully as a team member or independently
• Commitment to quality of work and company goals
• Enthusiastic to learn new systems and processes
• Willingness to lend your efforts wherever needed
• Effectively perform in stressful situations
• Complete work within assigned timeframe

Physical Demands:

• Ability to lift up to 50lbs and over 51lbs with assistance
• Ability to sit, stand, bend, crouch, kneel, climb, balance, push/pull, and walk for long periods of time
• Ability to enter and exit small, confined spaces
• Finger dexterity to work keyboard or operate tools, grasp tools and carry objects
• Ability to see in the normal range of vision with or without correction sufficient to read computer screens, documents, dials, gauges, meter-reading equipment, and operate motor vehicles and equipment
• Hear in the normal audio range with or without correction

Environmental Conditions:

Industrial environment working both indoors and outdoors continuously around:

• Loud noise
• Dust
• Heat
• Salt and fresh water
• Uneven, rough or slippery surfaces
• Hazardous chemicals in solid, liquid, and vapor form
• Toxic materials
• High and low voltage electricity
• Equipment under high pressure
• High speed rotating equipment
• Heavy equipment
• Heights above 5 Feet

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

JOB TITLE

Customs Engineer II

DEPARTMENT

MAIN PURPOSE OF JOB AND OBJECTIVES

• Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
• Performs custom product development activities, product evaluation, and testing, process development, test fixture development, verification/validation protocol and reports.

POSITION IN ORGANISATION

Position in organization can be found on the Organizational Chart via the company intranet.

KEY DUTIES

• Ensure adherence to Design Control procedures for standard and custom devices.
• Work with project leaders and supporting departments to complete project objectives.
• Develop, test, and refine prototypes and new product concepts.
• Finalize designs and create detailed engineering specifications ensuring proper tolerancing and design for manufacturability.
• Develop verification/validation protocols, carry out testing, and write reports.
• Evaluate competitor products.
• Develop new processes, test fixtures, and documentation methods.
• Work with Regulatory/ Quality group to carry out functionally specific testing.
• Work directly with Physicians/ Marketing to conceptualize new products, improve existing products and refine prototypes.
• Investigate field complaints and recommend actions/solutions.
• Manage product builds for formal testing programs.
• Assure Custom Design processes are in accordance with design control procedures.
• Develop project timeline for development projects and ensure project execution.
• Develop and implement new processes, test fixtures, and documentation methods.
• Take part in design reviews and technical product reviews.

COMPANY

REQUIREMENTS

• Must work within requirements of company handbook and policy statements.
• Note: Company Handbook, Policy Statement and Authorization of Limits do not form part of the quality system

QUALITY

REQUIREMENTS

• Maintain awareness of the relevance and importance of activities performed and how they contribute to the achievement of quality objectives.
• Work within the QMS always, ensure accurate completion of records and highlight issues to immediate supervisor any issues affecting quality.
• Responsible to ensure facility, processes and documentation remain in a state of audit readiness at all times.

EH&S REQUIREMENTS

• Take care of your own health and safety and that of others who may
• be affected by your actions.
• Work co-operatively to highlight issues affecting Environmental Health and Safety

QUALIFICATIONS & EXPERIENCE

• Excellent Written and Verbal Communication
• Ability to interact with all levels within the organization.
• Work well in a team environment
• Analytical skills for compiling and analyzing data.
• Computer and software skills
• Ability to motivate others and improve efficiency.
• Sit/Stand/Walk 8 hours per day.
• Light lifting
• Bachelor's degree in engineering/science and a minimum of three years' experience in the medical device industry or equivalent of
• 10+ years of experience in a technical role in the medical device industry
• Ability to organize and conduct experiments independently.
• Ability to analyze and solve technical problems.
• Good oral and written communication skills (English)
• Hands-on Experience building prototypes, developing in-vitro testing, capturing the output of in-vitro, and in-vivo testing, development of tooling and test fixtures.
• Understanding of quality system requirements (e.g. 21CFR820, ISO13485).
• Use of SolidWorks & AutoCAD as a design tool
• Knowledge of applied statistics
• Hands-on knowledge of plastics, metallurgy, and manufacturing processes
• Detailed knowledge of Design and Controls per ISO13485

JOB TITLE

Senior Manufacturing Engineer

DEPARTMENT

Manufacturing Engineer

JOB CODES

Contractor, 6 months

MAIN PURPOSE OF JOB AND OBJECTIVES

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

1. Performs process, tool, and gauge development and implementation activities, implement cost reductions, develop process layouts, develop, and maintain manufacturing instructions and device history records, and execute process validation protocols, builds and reports

KEY DUTIES

1. Work with Manufacturing Engineer Manager and / or Manufacturing Director to determine projects and related tasks.
2. Manage and lead projects and tasks.
3. Manage Tooling System including preventive maintenance, calibrations, and equipment records (if applicable)
4. Support & develop new processes that increase productivity and reduce cost.
5. Implement cost reductions via materials or manufacturing time.
6. Implement new process and issue process validation protocols and reports.
7. Develop fixtures, gigs, and gages.
8. Utilize Lean Manufacturing principles to increase productivity / throughput, reduce cost, and /or eliminate waste.
9. Document methods for manufacturing and inspection
10. Log evaluations into Engineering Notebooks
11. Perform Installation Qualification, Operational qualification, Test method validations, Computer/ software validation and Performance qualification as part of Manufacturing or equipment validation activities.
12. Perform time studies, process mapping, engineering testing, and DOE.
13. Utilize statistics to evaluate, justify, and support experiments, analysis, and validations.
14. Work with Mfg. Supervisor to analyze Manufacturing data, lead improvement projects that come from this analysis and group leader for Projects.
15. Available to support as a Manufacturing Engineer to support manufacturing Production overtime if it is required.
16. Develop, document (using AutoCAD / SolidWorks), and implement fixtures, jigs, tools, and gages.
17. Initiate process, design, and documentation changes through the change management process.
18. Perform Root Cause Investigations, develop and implement solutions.
19. Work with Mfg. Supervisor to analyze Manufacturing data and lead improvement projects that come from this analysis. (if applicable)

COMPANY

REQUIREMENTS

1. Must work within requirements of company handbook and policy statements

Note: Company Handbook, Policy Statement and Authorization of Limits do not form part of the quality system

QUALITY

REQUIREMENTS

1. Maintain awareness of the relevance and importance of activities performed and how they contribute to the achievement of quality objectives
2. Work within the QMS at all times, ensure accurate completion of records and highlight issues to immediate supervisor any issues affecting quality
3. Responsible to ensure facility, processes and documentation remain in a state of audit readiness at all times

EH&S REQUIREMENTS

1. Take care of your own health and safety and that of others who may
2. be affected by your actions
3. Work co-operatively to highlight issues affecting Environmental Health and Safety

1. QUALIFICATIONS & EXPERIENCE

1. Applies business understanding.
2. Technical leadership in an area of engineering core competency
3. Effective application of cross-functional and external resources to engineering activities
4. Subject matter expertise in QMS and design control requirements in area of engineering focus
5. Communicates effectively.
6. Effective cross-functional communication leadership skills
7. Preparation and delivery of effective technical presentations to senior management.
8. Developing organizational "presence" in communications
9. Demonstrates customer focus.
10. Provides functional leadership in applying understanding of engineering responsibilities to internal/external customers being supported.
11. Develop self and others.
12. Demonstrated understanding of engineering role and application of engineering skills with developing subject matter expertise
13. Developing mentor to lower position engineers
14. Drives improvement, innovation, and changes
15. Demonstrated innovative thinking and complex problem solving on product and process.
16. Embraces organizational change and leads improvement opportunities.
17. Takes accountability for results.
18. Completes individual and leads project teamwork activities as assigned demonstrating ability to effectively manage overall productivity and deliver strong technical results.
19. Bachelor’s degree in engineering/science and a minimum of (8) eight years’ experience in the medical device industry or (5) five years in the medical device industry with a master’s degree in engineering/science
20. Project management experience in the medical device industry
21. Hands-on knowledge of electronics, motion control, plastics, metrology, metallurgy, and manufacturing processes
22. Experience with polymers, medical grade metals and medical packaging
23. Ability to organize and conduct experiments independently.
24. Hands on abilities to engineer tooling, processes, and equipment.
25. Excellent written and verbal communication skills (English)
26. Hands on experience building prototypes, tooling, and fixtures.
27. Ability to analyze and solve technical problems.
28. Proficient in software applications